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Hypothermia confers no benefits in children with cardiac arrest
Comatose children who survived cardiac arrest in the hospital do not benefit more from treatment with therapeutic hypothermia than from keeping their body temperatures normal, according to results from a randomized trial conducted in 37 hospitals in three countries.
The findings were presented in Honolulu at the Critical Care Congress, sponsored by the Society for Critical Care Medicine, and published online Jan. 24 in the New England Journal of Medicine (2017 Jan 24. doi: 10.1056/NEJMoa1610493). They add to a growing consensus from adult studies that the use of induced hypothermia to prevent fevers and neurologic injury after cardiac arrest does not confer additional survival or functional benefit over normothermia. Less was known about children, particularly those whose cardiac arrest occurred in a hospital setting.
Frank W. Moler, MD, of the University of Michigan, Ann Arbor, led the study, which randomized 329 comatose children, from newborns to age 18 years, to either 120 hours of normothermia (target temperature, 36.8° C) or 48 hours of hypothermia (33°) followed by normal temperature maintenance to 120 days following an in-hospital cardiac arrest.
Fever prevention in both groups was achieved through active intervention, with hypothermia-treated patients also having been pharmacologically paralyzed and sedated. The investigators used the Vineland Adaptive Behavioral Scales to measure neurobehavioral function, with a score of 70 or higher deemed indicative of good function.
The study’s primary outcome was survival at 12 months after cardiac arrest and a favorable neurobehavioral outcome. In the 257 children with scores of 70 or higher before cardiac arrest, no significant differences were seen between the two different groups, with 36% of the hypothermia-treated patients (48/133) and 39% of normothermia-treated patients (48/124) surviving with a favorable neurobehavioral outcome (relative risk, 0.92; 95% confidence interval, 0.67-1.27; P = .63). In 317 children who could be evaluated for changes in neurobehavioral function, the changes from baseline between groups did not reach statistical significance (P = .70), and 1-year survival also did not differ significantly (49% for hypothermia-treated vs. 46% for normothermia; RR, 1.07; 95% CI, 0.85-1.34, P = .56). Adverse events did not differ significantly between groups.
The trial was stopped early for futility, leaving fewer than the hoped-for number of patients available for analysis, and wider confidence intervals. However, the investigators said their hypothesized 15 percentage point benefit for hypothermia treatment could be ruled out. Dr. Moler and his colleagues wrote in their analysis that unanswered questions remain regarding the role of body temperature interventions in this population, noting that different duration of treatment, different temperatures, and combination of temperature management with neuroprotective agents are worth considering for future studies. Dr. Moler and his colleagues’ study was funded by the National Heart, Lung, and Blood Institute. Four of its 49 coauthors disclosed commercial conflicts of interest.
Comatose children who survived cardiac arrest in the hospital do not benefit more from treatment with therapeutic hypothermia than from keeping their body temperatures normal, according to results from a randomized trial conducted in 37 hospitals in three countries.
The findings were presented in Honolulu at the Critical Care Congress, sponsored by the Society for Critical Care Medicine, and published online Jan. 24 in the New England Journal of Medicine (2017 Jan 24. doi: 10.1056/NEJMoa1610493). They add to a growing consensus from adult studies that the use of induced hypothermia to prevent fevers and neurologic injury after cardiac arrest does not confer additional survival or functional benefit over normothermia. Less was known about children, particularly those whose cardiac arrest occurred in a hospital setting.
Frank W. Moler, MD, of the University of Michigan, Ann Arbor, led the study, which randomized 329 comatose children, from newborns to age 18 years, to either 120 hours of normothermia (target temperature, 36.8° C) or 48 hours of hypothermia (33°) followed by normal temperature maintenance to 120 days following an in-hospital cardiac arrest.
Fever prevention in both groups was achieved through active intervention, with hypothermia-treated patients also having been pharmacologically paralyzed and sedated. The investigators used the Vineland Adaptive Behavioral Scales to measure neurobehavioral function, with a score of 70 or higher deemed indicative of good function.
The study’s primary outcome was survival at 12 months after cardiac arrest and a favorable neurobehavioral outcome. In the 257 children with scores of 70 or higher before cardiac arrest, no significant differences were seen between the two different groups, with 36% of the hypothermia-treated patients (48/133) and 39% of normothermia-treated patients (48/124) surviving with a favorable neurobehavioral outcome (relative risk, 0.92; 95% confidence interval, 0.67-1.27; P = .63). In 317 children who could be evaluated for changes in neurobehavioral function, the changes from baseline between groups did not reach statistical significance (P = .70), and 1-year survival also did not differ significantly (49% for hypothermia-treated vs. 46% for normothermia; RR, 1.07; 95% CI, 0.85-1.34, P = .56). Adverse events did not differ significantly between groups.
The trial was stopped early for futility, leaving fewer than the hoped-for number of patients available for analysis, and wider confidence intervals. However, the investigators said their hypothesized 15 percentage point benefit for hypothermia treatment could be ruled out. Dr. Moler and his colleagues wrote in their analysis that unanswered questions remain regarding the role of body temperature interventions in this population, noting that different duration of treatment, different temperatures, and combination of temperature management with neuroprotective agents are worth considering for future studies. Dr. Moler and his colleagues’ study was funded by the National Heart, Lung, and Blood Institute. Four of its 49 coauthors disclosed commercial conflicts of interest.
Comatose children who survived cardiac arrest in the hospital do not benefit more from treatment with therapeutic hypothermia than from keeping their body temperatures normal, according to results from a randomized trial conducted in 37 hospitals in three countries.
The findings were presented in Honolulu at the Critical Care Congress, sponsored by the Society for Critical Care Medicine, and published online Jan. 24 in the New England Journal of Medicine (2017 Jan 24. doi: 10.1056/NEJMoa1610493). They add to a growing consensus from adult studies that the use of induced hypothermia to prevent fevers and neurologic injury after cardiac arrest does not confer additional survival or functional benefit over normothermia. Less was known about children, particularly those whose cardiac arrest occurred in a hospital setting.
Frank W. Moler, MD, of the University of Michigan, Ann Arbor, led the study, which randomized 329 comatose children, from newborns to age 18 years, to either 120 hours of normothermia (target temperature, 36.8° C) or 48 hours of hypothermia (33°) followed by normal temperature maintenance to 120 days following an in-hospital cardiac arrest.
Fever prevention in both groups was achieved through active intervention, with hypothermia-treated patients also having been pharmacologically paralyzed and sedated. The investigators used the Vineland Adaptive Behavioral Scales to measure neurobehavioral function, with a score of 70 or higher deemed indicative of good function.
The study’s primary outcome was survival at 12 months after cardiac arrest and a favorable neurobehavioral outcome. In the 257 children with scores of 70 or higher before cardiac arrest, no significant differences were seen between the two different groups, with 36% of the hypothermia-treated patients (48/133) and 39% of normothermia-treated patients (48/124) surviving with a favorable neurobehavioral outcome (relative risk, 0.92; 95% confidence interval, 0.67-1.27; P = .63). In 317 children who could be evaluated for changes in neurobehavioral function, the changes from baseline between groups did not reach statistical significance (P = .70), and 1-year survival also did not differ significantly (49% for hypothermia-treated vs. 46% for normothermia; RR, 1.07; 95% CI, 0.85-1.34, P = .56). Adverse events did not differ significantly between groups.
The trial was stopped early for futility, leaving fewer than the hoped-for number of patients available for analysis, and wider confidence intervals. However, the investigators said their hypothesized 15 percentage point benefit for hypothermia treatment could be ruled out. Dr. Moler and his colleagues wrote in their analysis that unanswered questions remain regarding the role of body temperature interventions in this population, noting that different duration of treatment, different temperatures, and combination of temperature management with neuroprotective agents are worth considering for future studies. Dr. Moler and his colleagues’ study was funded by the National Heart, Lung, and Blood Institute. Four of its 49 coauthors disclosed commercial conflicts of interest.
FROM THE CRITICAL CARE CONGRESS
Key clinical point: Treating comatose children with hypothermia following cardiac arrest did not produce better neurobehavioral or survival outcomes at 1 year, compared with children whose body temperatures were held to normal.
Major finding: 36% of hypothermia-treated patients and 39% of normothermia-treated patients survived with a favorable neurobehavioral outcome (RR, 0.92; 95% CI, 0.67-1.27; P = .63).
Data source: A multisite, international trial randomizing 329 infants and children comatose after cardiac arrest while in hospital to hypothermia or normothermia.
Disclosures: The National Heart, Lung, and Blood Institute sponsored the study. Several investigators disclosed National Institutes of Health or university funding while four disclosed commercial conflicts.
Delirium prevention, treatment lags in the ICU, survey suggests
ORLANDO – Most of the ICU directors responding to a survey had delirium screening protocols in place, but said their current practices don’t conform to best practice guidelines.
“While most ICUs have protocols that incorporate delirium screening with a validated tool, most perceived current delirium prevention and treatment strategies do not reflect best evidence or current pain, agitation, and delirium practice guidelines,” senior author Amy Dzierba, Pharm.D., said in an interview. Practice guidelines for pain, agitation, and delirium in the ICU, promulgated jointly by the American College of Critical Care Medicine (ACCM) and the Society of Critical Care Medicine (SCCM) in 2013, call for ICU patients to be screened regularly for delirium, and recommend non-pharmacologic and pharmacologic interventions to prevent, or reduce the duration of, delirium in critically ill adults.
The Critical Care Pharmacy Trials Network (CCPTN) initiated the survey. Responses came from 19 hospitals with 42 ICUs, with 74% of them being academic medical centers and the remainder teaching community hospitals. Joshua Swan, Pharm.D. of Texas Southern University, Houston, presented the study findings at the Society for Critical Care Medicine’s annual Critical Care Congress.
The multicenter, observational, cross-sectional study used a validated, web-based survey that included questions about demographic characteristics of the ICUs, as well as a series of 36 questions about perceptions of delirium screening, prevention, and treatment practices.
Most ICUs (26/42, 62%) used the Confusion Assessment Method for the ICU (CAM-ICU), while another 10 hospitals (24%) used the Intensive Care Delirium Screening Checklist Worksheet (ICDSC). The other hospitals used physician or nurse opinion, or another method.
Twenty-two of 42 respondents (58%) judged that they screened for delirium twice daily; 10 ICUs thought they screened three times daily, three screened once daily, and the rest thought they screened more frequently than twice daily.
A non-pharmacologic delirium prevention and reduction protocol was in place for 33 (80%) of the ICUs. Specific interventions that respondents judged they used, regardless of delirium presence, included reorientation in more than 80% of ICUs, catheter and restraint removal in more than 70% of ICUs responding, and ensuring eyeglasses were donned for about 70% of ICUs.
Less frequently-used interventions were provision of hearing aids, early mobilization, reduction of unnecessary noise and stimulation, music therapy, provision of earplugs, and cognitive exercises.
About half of survey respondents said that their ICUs used early mobilization as a delirium prevention strategy.
“We thought that early mobilization would be used more frequently,” said Dr. Dzierba, clinical pharmacy manager for adult critical care at Columbia University Medical Center’s New York-Presbyterian Hospital. She noted, however, that respondents may be utilizing this strategy and others some of the time, without having formalized policies. Also, administrative and logistical challenges, such as ICU staffing models, may create barriers to implementing early mobilization and other non-pharmacologic approached to preventing and managing delirium.
Perceived pharmacologic strategies that were used in about half of the ICUs for patients without delirium included avoidance of benzodiazepines for sedation, minimization of anticholinergic medication, and minimization of caffeine.
About half of survey respondents reported that they scheduled atypical antipsychotic medication for their patients with delirium, while about 40% reported they used as needed atypical antipsychotic medication. About 30% of ICUs said they were substituting propofol for benzodiazepines in continuous infusion; about 30% of ICUs thought they used PRN haloperidol for delirium. Fewer than 20% of responding ICUs said they substituted PRN for continuously infused benzodiazepines, used scheduled haloperidol, or used other pharmacologic regimes.
“Future studies should compare actual practices to those that are perceived, which we plan to accomplish using data from the second part of our study,” Dr. Dzierba said.
Dr. Dzierba reported no external source of funding for the study, and the authors had no relevant conflicts of interest to disclose.
On Twitter @karioakes
ORLANDO – Most of the ICU directors responding to a survey had delirium screening protocols in place, but said their current practices don’t conform to best practice guidelines.
“While most ICUs have protocols that incorporate delirium screening with a validated tool, most perceived current delirium prevention and treatment strategies do not reflect best evidence or current pain, agitation, and delirium practice guidelines,” senior author Amy Dzierba, Pharm.D., said in an interview. Practice guidelines for pain, agitation, and delirium in the ICU, promulgated jointly by the American College of Critical Care Medicine (ACCM) and the Society of Critical Care Medicine (SCCM) in 2013, call for ICU patients to be screened regularly for delirium, and recommend non-pharmacologic and pharmacologic interventions to prevent, or reduce the duration of, delirium in critically ill adults.
The Critical Care Pharmacy Trials Network (CCPTN) initiated the survey. Responses came from 19 hospitals with 42 ICUs, with 74% of them being academic medical centers and the remainder teaching community hospitals. Joshua Swan, Pharm.D. of Texas Southern University, Houston, presented the study findings at the Society for Critical Care Medicine’s annual Critical Care Congress.
The multicenter, observational, cross-sectional study used a validated, web-based survey that included questions about demographic characteristics of the ICUs, as well as a series of 36 questions about perceptions of delirium screening, prevention, and treatment practices.
Most ICUs (26/42, 62%) used the Confusion Assessment Method for the ICU (CAM-ICU), while another 10 hospitals (24%) used the Intensive Care Delirium Screening Checklist Worksheet (ICDSC). The other hospitals used physician or nurse opinion, or another method.
Twenty-two of 42 respondents (58%) judged that they screened for delirium twice daily; 10 ICUs thought they screened three times daily, three screened once daily, and the rest thought they screened more frequently than twice daily.
A non-pharmacologic delirium prevention and reduction protocol was in place for 33 (80%) of the ICUs. Specific interventions that respondents judged they used, regardless of delirium presence, included reorientation in more than 80% of ICUs, catheter and restraint removal in more than 70% of ICUs responding, and ensuring eyeglasses were donned for about 70% of ICUs.
Less frequently-used interventions were provision of hearing aids, early mobilization, reduction of unnecessary noise and stimulation, music therapy, provision of earplugs, and cognitive exercises.
About half of survey respondents said that their ICUs used early mobilization as a delirium prevention strategy.
“We thought that early mobilization would be used more frequently,” said Dr. Dzierba, clinical pharmacy manager for adult critical care at Columbia University Medical Center’s New York-Presbyterian Hospital. She noted, however, that respondents may be utilizing this strategy and others some of the time, without having formalized policies. Also, administrative and logistical challenges, such as ICU staffing models, may create barriers to implementing early mobilization and other non-pharmacologic approached to preventing and managing delirium.
Perceived pharmacologic strategies that were used in about half of the ICUs for patients without delirium included avoidance of benzodiazepines for sedation, minimization of anticholinergic medication, and minimization of caffeine.
About half of survey respondents reported that they scheduled atypical antipsychotic medication for their patients with delirium, while about 40% reported they used as needed atypical antipsychotic medication. About 30% of ICUs said they were substituting propofol for benzodiazepines in continuous infusion; about 30% of ICUs thought they used PRN haloperidol for delirium. Fewer than 20% of responding ICUs said they substituted PRN for continuously infused benzodiazepines, used scheduled haloperidol, or used other pharmacologic regimes.
“Future studies should compare actual practices to those that are perceived, which we plan to accomplish using data from the second part of our study,” Dr. Dzierba said.
Dr. Dzierba reported no external source of funding for the study, and the authors had no relevant conflicts of interest to disclose.
On Twitter @karioakes
ORLANDO – Most of the ICU directors responding to a survey had delirium screening protocols in place, but said their current practices don’t conform to best practice guidelines.
“While most ICUs have protocols that incorporate delirium screening with a validated tool, most perceived current delirium prevention and treatment strategies do not reflect best evidence or current pain, agitation, and delirium practice guidelines,” senior author Amy Dzierba, Pharm.D., said in an interview. Practice guidelines for pain, agitation, and delirium in the ICU, promulgated jointly by the American College of Critical Care Medicine (ACCM) and the Society of Critical Care Medicine (SCCM) in 2013, call for ICU patients to be screened regularly for delirium, and recommend non-pharmacologic and pharmacologic interventions to prevent, or reduce the duration of, delirium in critically ill adults.
The Critical Care Pharmacy Trials Network (CCPTN) initiated the survey. Responses came from 19 hospitals with 42 ICUs, with 74% of them being academic medical centers and the remainder teaching community hospitals. Joshua Swan, Pharm.D. of Texas Southern University, Houston, presented the study findings at the Society for Critical Care Medicine’s annual Critical Care Congress.
The multicenter, observational, cross-sectional study used a validated, web-based survey that included questions about demographic characteristics of the ICUs, as well as a series of 36 questions about perceptions of delirium screening, prevention, and treatment practices.
Most ICUs (26/42, 62%) used the Confusion Assessment Method for the ICU (CAM-ICU), while another 10 hospitals (24%) used the Intensive Care Delirium Screening Checklist Worksheet (ICDSC). The other hospitals used physician or nurse opinion, or another method.
Twenty-two of 42 respondents (58%) judged that they screened for delirium twice daily; 10 ICUs thought they screened three times daily, three screened once daily, and the rest thought they screened more frequently than twice daily.
A non-pharmacologic delirium prevention and reduction protocol was in place for 33 (80%) of the ICUs. Specific interventions that respondents judged they used, regardless of delirium presence, included reorientation in more than 80% of ICUs, catheter and restraint removal in more than 70% of ICUs responding, and ensuring eyeglasses were donned for about 70% of ICUs.
Less frequently-used interventions were provision of hearing aids, early mobilization, reduction of unnecessary noise and stimulation, music therapy, provision of earplugs, and cognitive exercises.
About half of survey respondents said that their ICUs used early mobilization as a delirium prevention strategy.
“We thought that early mobilization would be used more frequently,” said Dr. Dzierba, clinical pharmacy manager for adult critical care at Columbia University Medical Center’s New York-Presbyterian Hospital. She noted, however, that respondents may be utilizing this strategy and others some of the time, without having formalized policies. Also, administrative and logistical challenges, such as ICU staffing models, may create barriers to implementing early mobilization and other non-pharmacologic approached to preventing and managing delirium.
Perceived pharmacologic strategies that were used in about half of the ICUs for patients without delirium included avoidance of benzodiazepines for sedation, minimization of anticholinergic medication, and minimization of caffeine.
About half of survey respondents reported that they scheduled atypical antipsychotic medication for their patients with delirium, while about 40% reported they used as needed atypical antipsychotic medication. About 30% of ICUs said they were substituting propofol for benzodiazepines in continuous infusion; about 30% of ICUs thought they used PRN haloperidol for delirium. Fewer than 20% of responding ICUs said they substituted PRN for continuously infused benzodiazepines, used scheduled haloperidol, or used other pharmacologic regimes.
“Future studies should compare actual practices to those that are perceived, which we plan to accomplish using data from the second part of our study,” Dr. Dzierba said.
Dr. Dzierba reported no external source of funding for the study, and the authors had no relevant conflicts of interest to disclose.
On Twitter @karioakes
AT THE CRITICAL CARE CONGRESS
Key clinical point: Most ICUs have delirium screening protocols, but prevention and treatment strategies lag.
Major finding: About half of ICUs reported using early mobilization as a strategy for delirium prevention and management.
Data source: Survey of 42 ICUs in the U.S.
Disclosures: Dr. Dzierba and Dr. Swan disclosed no conflicts of interest. The study had no external sources of funding.
Infection rates similar for in- and out-of-hospital pediatric cardiac arrest
ORLANDO – Infection rates didn’t differ between children who suffered cardiac arrest in or out of the hospital, and in both groups, few children’s infections were confirmed by culture, in a multicenter study.
The study explored infectious complications associated with pediatric cardiac arrest, Dr. Fasiha Saeed said at the Critical Care Congress, sponsored by the Society of Critical Care Medicine.
She and her colleagues examined records of 491 pediatric patients who had return of spontaneous circulation after cardiac arrest (CA), 269 in hospital (IH) and 115 out of hospital (OH). Overall, more children who had in-hospital cardiac arrest were suspected of having an infection (242 [90%], compared with 83 [74%], in the OHCA group; P less than 0.0001).
However, cultures were actually sent for only about one in three patients with suspected infection in either group (34% IHCA and 35% OHCA). Definite infection was found in most patients who were cultured (82% and 86%, respectively).
Patients had “suspected infection” if they received cultures or antimicrobials, and were termed to have “definite infection” only if cultures were positive for infection.
“Infectious complications following out-of-hospital cardiac arrest have been reported in the adult literature, but the pediatric experience post–cardiac arrest is limited to case reports and small case series,” said Dr. Saeed, a pediatric critical care physician at Advocate Hospital, Park Ridge, Ill.
Data from PECARN (Pediatric Emergency Care Applied Research Network) had previously shown that in-hospital pediatric cardiac arrest patients were more likely to receive antimicrobials after return of spontaneous circulation. However, infectious etiologies and the early hospital course of these patients after their cardiac arrest was not known, said Dr. Saeed.
Dr. Saeed and her coinvestigators had hypothesized that “children with out-of-hospital cardiac arrest have a higher incidence of infections after return of spontaneous circulation and worse outcomes compared to children with in-hospital cardiac arrest,” she said. “We were surprised to see how infrequently cultures were sent,” said Dr. Saeed, in discussing the findings that were contrary to the study’s hypothesis.
Dr. Saeed and her colleagues conducted a retrospective analysis of the multi-institutional, deidentified PECARN database, examining 491 pediatric cardiac arrest patients who had required at least 1 minute of cardiopulmonary resuscitation. The patients were aged 24 hours to 18 years; the period of data collection was July 2003-December 2004.
Exclusion criteria included a diagnosis of septic shock, the use of therapeutic hypothermia, or patient death within 24 hours of the cardiac arrest.
Among other findings presented by Dr. Saeed, no association was seen between either suspected or definite infection and mortality. Antibiotic usage was also not associated with mortality. However, definite infection was positively associated with a respiratory etiology for cardiac arrest (odds ratio, 2.6). Post–cardiac arrest central venous pressure monitoring was also associated with definite infection (OR, 2.1).
Support for the study was provided by the Medical College of Wisconsin. The investigators disclosed no relevant conflicts of interest.
On Twitter @karioakes
ORLANDO – Infection rates didn’t differ between children who suffered cardiac arrest in or out of the hospital, and in both groups, few children’s infections were confirmed by culture, in a multicenter study.
The study explored infectious complications associated with pediatric cardiac arrest, Dr. Fasiha Saeed said at the Critical Care Congress, sponsored by the Society of Critical Care Medicine.
She and her colleagues examined records of 491 pediatric patients who had return of spontaneous circulation after cardiac arrest (CA), 269 in hospital (IH) and 115 out of hospital (OH). Overall, more children who had in-hospital cardiac arrest were suspected of having an infection (242 [90%], compared with 83 [74%], in the OHCA group; P less than 0.0001).
However, cultures were actually sent for only about one in three patients with suspected infection in either group (34% IHCA and 35% OHCA). Definite infection was found in most patients who were cultured (82% and 86%, respectively).
Patients had “suspected infection” if they received cultures or antimicrobials, and were termed to have “definite infection” only if cultures were positive for infection.
“Infectious complications following out-of-hospital cardiac arrest have been reported in the adult literature, but the pediatric experience post–cardiac arrest is limited to case reports and small case series,” said Dr. Saeed, a pediatric critical care physician at Advocate Hospital, Park Ridge, Ill.
Data from PECARN (Pediatric Emergency Care Applied Research Network) had previously shown that in-hospital pediatric cardiac arrest patients were more likely to receive antimicrobials after return of spontaneous circulation. However, infectious etiologies and the early hospital course of these patients after their cardiac arrest was not known, said Dr. Saeed.
Dr. Saeed and her coinvestigators had hypothesized that “children with out-of-hospital cardiac arrest have a higher incidence of infections after return of spontaneous circulation and worse outcomes compared to children with in-hospital cardiac arrest,” she said. “We were surprised to see how infrequently cultures were sent,” said Dr. Saeed, in discussing the findings that were contrary to the study’s hypothesis.
Dr. Saeed and her colleagues conducted a retrospective analysis of the multi-institutional, deidentified PECARN database, examining 491 pediatric cardiac arrest patients who had required at least 1 minute of cardiopulmonary resuscitation. The patients were aged 24 hours to 18 years; the period of data collection was July 2003-December 2004.
Exclusion criteria included a diagnosis of septic shock, the use of therapeutic hypothermia, or patient death within 24 hours of the cardiac arrest.
Among other findings presented by Dr. Saeed, no association was seen between either suspected or definite infection and mortality. Antibiotic usage was also not associated with mortality. However, definite infection was positively associated with a respiratory etiology for cardiac arrest (odds ratio, 2.6). Post–cardiac arrest central venous pressure monitoring was also associated with definite infection (OR, 2.1).
Support for the study was provided by the Medical College of Wisconsin. The investigators disclosed no relevant conflicts of interest.
On Twitter @karioakes
ORLANDO – Infection rates didn’t differ between children who suffered cardiac arrest in or out of the hospital, and in both groups, few children’s infections were confirmed by culture, in a multicenter study.
The study explored infectious complications associated with pediatric cardiac arrest, Dr. Fasiha Saeed said at the Critical Care Congress, sponsored by the Society of Critical Care Medicine.
She and her colleagues examined records of 491 pediatric patients who had return of spontaneous circulation after cardiac arrest (CA), 269 in hospital (IH) and 115 out of hospital (OH). Overall, more children who had in-hospital cardiac arrest were suspected of having an infection (242 [90%], compared with 83 [74%], in the OHCA group; P less than 0.0001).
However, cultures were actually sent for only about one in three patients with suspected infection in either group (34% IHCA and 35% OHCA). Definite infection was found in most patients who were cultured (82% and 86%, respectively).
Patients had “suspected infection” if they received cultures or antimicrobials, and were termed to have “definite infection” only if cultures were positive for infection.
“Infectious complications following out-of-hospital cardiac arrest have been reported in the adult literature, but the pediatric experience post–cardiac arrest is limited to case reports and small case series,” said Dr. Saeed, a pediatric critical care physician at Advocate Hospital, Park Ridge, Ill.
Data from PECARN (Pediatric Emergency Care Applied Research Network) had previously shown that in-hospital pediatric cardiac arrest patients were more likely to receive antimicrobials after return of spontaneous circulation. However, infectious etiologies and the early hospital course of these patients after their cardiac arrest was not known, said Dr. Saeed.
Dr. Saeed and her coinvestigators had hypothesized that “children with out-of-hospital cardiac arrest have a higher incidence of infections after return of spontaneous circulation and worse outcomes compared to children with in-hospital cardiac arrest,” she said. “We were surprised to see how infrequently cultures were sent,” said Dr. Saeed, in discussing the findings that were contrary to the study’s hypothesis.
Dr. Saeed and her colleagues conducted a retrospective analysis of the multi-institutional, deidentified PECARN database, examining 491 pediatric cardiac arrest patients who had required at least 1 minute of cardiopulmonary resuscitation. The patients were aged 24 hours to 18 years; the period of data collection was July 2003-December 2004.
Exclusion criteria included a diagnosis of septic shock, the use of therapeutic hypothermia, or patient death within 24 hours of the cardiac arrest.
Among other findings presented by Dr. Saeed, no association was seen between either suspected or definite infection and mortality. Antibiotic usage was also not associated with mortality. However, definite infection was positively associated with a respiratory etiology for cardiac arrest (odds ratio, 2.6). Post–cardiac arrest central venous pressure monitoring was also associated with definite infection (OR, 2.1).
Support for the study was provided by the Medical College of Wisconsin. The investigators disclosed no relevant conflicts of interest.
On Twitter @karioakes
AT THE CRITICAL CARE CONGRESS
Key clinical point: Postresuscitation infection rates were similar for in- and out-of-hospital pediatric cardiac arrest (IHCA and OHCA).
Major finding: More patients who had in-hospital arrest were suspected of having infection, Definite infection was found in most patients who were cultured (68/83 [82%] IHCA, and 25/29 [86%] OHCA).
Data source: Retrospective review of records of 491 pediatric patients who suffered cardiac arrest and had spontaneous return of circulation, drawn from the PECARN (Pediatric Emergency Care Applied Research Network) database.
Disclosures: Support for the study was provided by the Medical College of Wisconsin. The investigators disclosed no relevant conflicts of interest.
Thiamine repletion promising strategy in septic shock
ORLANDO – Thiamine supplementation improved in-hospital survival for thiamine-deficient patients with septic shock, and reduced progression to dialysis regardless of baseline thiamine status, in a pilot study.
The prospective, randomized, double-blind placebo-controlled trial compared daily 200-mg intravenous doses of thiamine to placebo for 88 patients hospitalized with septic shock. Thiamine was given for 7 consecutive days, or until discharge. On entry into the clinical trial, median lactate was the same in both the thiamine (n = 43) and the placebo arm (n = 45) at 4.1 mmol/L, Dr. Michael Donnino said during a late-breaking session at the Society for Critical Care Medicine’s Critical Care Congress.
At 24 hours, median lactate had dropped to 2.5 mmol/L in the thiamine group and 2.6 mmol/L in the placebo group, a nonsignificant difference. There was no significant difference in shock reversal between groups, nor was there a difference in time to shock or cumulative vasopressor dose.
However, the thiamine group had fewer patients with markedly elevated lactate at 24 hours: 17 (38%) of the placebo group had lactate levels greater than 4 mmol/L, compared with 9 (21%) of the thiamine group. “There were many more ‘lactate outliers’ in the placebo arm, and those virtually disappeared in the thiamine treatment arm,” said Dr. Donnino, director of the center for resuscitation science at Beth Israel Deaconess Medical Center, Boston.
For patients who were thiamine deficient and received thiamine repletion, a preplanned subgroup analysis of these 28 patients (35%) showed significantly lower lactate at 24 hours (median, 2.1 mmol/L vs, 3.1; P = .03). “In this group we saw a lot different physiology,” said Dr. Donnino. “Change was different; median was different; any way you looked at these data, lactate was lower in the thiamine group.”
For the full group of participants, there was no significant between-group difference in overall survival. Of the 15 thiamine-deficient patients who received thiamine, 2 (13%) patients died, while 6 (46%) of the 13 thiamine-deficient patients in the placebo arm died, a nonsignificant difference (P = .10), but there was a significant difference between the survival curves of the two groups (P = .047).
In a post hoc analysis not contained in the concurrently published article , only one of the patients in the thiamine arm (3%) progressed to renal injury requiring dialysis, while eight patients in the placebo arm (23%) needed dialysis (P = .04) (Crit Care Med. 2016 Feb;44[2]:360-7. doi: 10.1097/CCM.0000000000001572).
“I would argue that an often forgotten – but key – component of pyruvate dehydrogenase is thiamine. … Without thiamine, you get refractory hypotension, lactic acidosis, and death,” Dr. Donnino said.
Adult patients were included in the study if they had a suspected or confirmed source of infection, and remained hypotensive (with a systolic blood pressure of less than 90 mm Hg) after a 2-L fluid bolus, with subsequent vasopressor dependence. Vasopressor dependence in the study was defined as continuous infusion of norepinephrine or epinephrine, or of dopamine at 5 mcg/kg per minute or greater.
The final criterion for inclusion was lactate greater than 3 mmol/dL after the initial fluid bolus. “Interestingly, if you change that 3 to 2, this is very similar to the current definition of septic shock,” said Dr. Donnino.
The primary endpoint of the study was median lactate level at 24 hours, with secondary endpoints of lactate change at 24 hours, shock reversal, and mortality. Adverse events and mortality were the safety endpoints.
Baseline characteristics were similar for both study arms, except that the thiamine group had a higher proportion of patients with diabetes than the placebo group (17/43 [40%] vs. 6/45 [13%]).
The study excluded cases in which lactic acidosis might be due to reasons other than septic shock, such as recent seizures, use of medications that can cause lactic acidosis, ischemia, and carbon monoxide poisoning. Patients who had another indication for thiamine administration, such as those in acute alcohol withdrawal, were excluded as well.
Some data analysis was hampered by the high in-hospital mortality rate of 43%. Also, the study involved a target population of critically ill patients, drawn mostly from a single center.
Bringing the discussion to the real world, moderator Dr. Timothy Buchman, director of the critical care center at Emory University, Atlanta, asked, “Today, when you see a patient in sepsis, do you routinely give thiamine?”
Dr. Donnino responded, “When I see someone in septic shock with a persistent lactic acidosis who I consider to be in a risk category, my clinical practice is to give them thiamine now. I’m not necessarily saying that I advocate that to the wider critical care community based on our data, but that’s just based on my experience and what I’ve seen over the years.”
The study was funded by the National Institutes of Health. Dr. Donnino and his coauthors reported no relevant financial disclolsures.
On Twitter @karioakes
ORLANDO – Thiamine supplementation improved in-hospital survival for thiamine-deficient patients with septic shock, and reduced progression to dialysis regardless of baseline thiamine status, in a pilot study.
The prospective, randomized, double-blind placebo-controlled trial compared daily 200-mg intravenous doses of thiamine to placebo for 88 patients hospitalized with septic shock. Thiamine was given for 7 consecutive days, or until discharge. On entry into the clinical trial, median lactate was the same in both the thiamine (n = 43) and the placebo arm (n = 45) at 4.1 mmol/L, Dr. Michael Donnino said during a late-breaking session at the Society for Critical Care Medicine’s Critical Care Congress.
At 24 hours, median lactate had dropped to 2.5 mmol/L in the thiamine group and 2.6 mmol/L in the placebo group, a nonsignificant difference. There was no significant difference in shock reversal between groups, nor was there a difference in time to shock or cumulative vasopressor dose.
However, the thiamine group had fewer patients with markedly elevated lactate at 24 hours: 17 (38%) of the placebo group had lactate levels greater than 4 mmol/L, compared with 9 (21%) of the thiamine group. “There were many more ‘lactate outliers’ in the placebo arm, and those virtually disappeared in the thiamine treatment arm,” said Dr. Donnino, director of the center for resuscitation science at Beth Israel Deaconess Medical Center, Boston.
For patients who were thiamine deficient and received thiamine repletion, a preplanned subgroup analysis of these 28 patients (35%) showed significantly lower lactate at 24 hours (median, 2.1 mmol/L vs, 3.1; P = .03). “In this group we saw a lot different physiology,” said Dr. Donnino. “Change was different; median was different; any way you looked at these data, lactate was lower in the thiamine group.”
For the full group of participants, there was no significant between-group difference in overall survival. Of the 15 thiamine-deficient patients who received thiamine, 2 (13%) patients died, while 6 (46%) of the 13 thiamine-deficient patients in the placebo arm died, a nonsignificant difference (P = .10), but there was a significant difference between the survival curves of the two groups (P = .047).
In a post hoc analysis not contained in the concurrently published article , only one of the patients in the thiamine arm (3%) progressed to renal injury requiring dialysis, while eight patients in the placebo arm (23%) needed dialysis (P = .04) (Crit Care Med. 2016 Feb;44[2]:360-7. doi: 10.1097/CCM.0000000000001572).
“I would argue that an often forgotten – but key – component of pyruvate dehydrogenase is thiamine. … Without thiamine, you get refractory hypotension, lactic acidosis, and death,” Dr. Donnino said.
Adult patients were included in the study if they had a suspected or confirmed source of infection, and remained hypotensive (with a systolic blood pressure of less than 90 mm Hg) after a 2-L fluid bolus, with subsequent vasopressor dependence. Vasopressor dependence in the study was defined as continuous infusion of norepinephrine or epinephrine, or of dopamine at 5 mcg/kg per minute or greater.
The final criterion for inclusion was lactate greater than 3 mmol/dL after the initial fluid bolus. “Interestingly, if you change that 3 to 2, this is very similar to the current definition of septic shock,” said Dr. Donnino.
The primary endpoint of the study was median lactate level at 24 hours, with secondary endpoints of lactate change at 24 hours, shock reversal, and mortality. Adverse events and mortality were the safety endpoints.
Baseline characteristics were similar for both study arms, except that the thiamine group had a higher proportion of patients with diabetes than the placebo group (17/43 [40%] vs. 6/45 [13%]).
The study excluded cases in which lactic acidosis might be due to reasons other than septic shock, such as recent seizures, use of medications that can cause lactic acidosis, ischemia, and carbon monoxide poisoning. Patients who had another indication for thiamine administration, such as those in acute alcohol withdrawal, were excluded as well.
Some data analysis was hampered by the high in-hospital mortality rate of 43%. Also, the study involved a target population of critically ill patients, drawn mostly from a single center.
Bringing the discussion to the real world, moderator Dr. Timothy Buchman, director of the critical care center at Emory University, Atlanta, asked, “Today, when you see a patient in sepsis, do you routinely give thiamine?”
Dr. Donnino responded, “When I see someone in septic shock with a persistent lactic acidosis who I consider to be in a risk category, my clinical practice is to give them thiamine now. I’m not necessarily saying that I advocate that to the wider critical care community based on our data, but that’s just based on my experience and what I’ve seen over the years.”
The study was funded by the National Institutes of Health. Dr. Donnino and his coauthors reported no relevant financial disclolsures.
On Twitter @karioakes
ORLANDO – Thiamine supplementation improved in-hospital survival for thiamine-deficient patients with septic shock, and reduced progression to dialysis regardless of baseline thiamine status, in a pilot study.
The prospective, randomized, double-blind placebo-controlled trial compared daily 200-mg intravenous doses of thiamine to placebo for 88 patients hospitalized with septic shock. Thiamine was given for 7 consecutive days, or until discharge. On entry into the clinical trial, median lactate was the same in both the thiamine (n = 43) and the placebo arm (n = 45) at 4.1 mmol/L, Dr. Michael Donnino said during a late-breaking session at the Society for Critical Care Medicine’s Critical Care Congress.
At 24 hours, median lactate had dropped to 2.5 mmol/L in the thiamine group and 2.6 mmol/L in the placebo group, a nonsignificant difference. There was no significant difference in shock reversal between groups, nor was there a difference in time to shock or cumulative vasopressor dose.
However, the thiamine group had fewer patients with markedly elevated lactate at 24 hours: 17 (38%) of the placebo group had lactate levels greater than 4 mmol/L, compared with 9 (21%) of the thiamine group. “There were many more ‘lactate outliers’ in the placebo arm, and those virtually disappeared in the thiamine treatment arm,” said Dr. Donnino, director of the center for resuscitation science at Beth Israel Deaconess Medical Center, Boston.
For patients who were thiamine deficient and received thiamine repletion, a preplanned subgroup analysis of these 28 patients (35%) showed significantly lower lactate at 24 hours (median, 2.1 mmol/L vs, 3.1; P = .03). “In this group we saw a lot different physiology,” said Dr. Donnino. “Change was different; median was different; any way you looked at these data, lactate was lower in the thiamine group.”
For the full group of participants, there was no significant between-group difference in overall survival. Of the 15 thiamine-deficient patients who received thiamine, 2 (13%) patients died, while 6 (46%) of the 13 thiamine-deficient patients in the placebo arm died, a nonsignificant difference (P = .10), but there was a significant difference between the survival curves of the two groups (P = .047).
In a post hoc analysis not contained in the concurrently published article , only one of the patients in the thiamine arm (3%) progressed to renal injury requiring dialysis, while eight patients in the placebo arm (23%) needed dialysis (P = .04) (Crit Care Med. 2016 Feb;44[2]:360-7. doi: 10.1097/CCM.0000000000001572).
“I would argue that an often forgotten – but key – component of pyruvate dehydrogenase is thiamine. … Without thiamine, you get refractory hypotension, lactic acidosis, and death,” Dr. Donnino said.
Adult patients were included in the study if they had a suspected or confirmed source of infection, and remained hypotensive (with a systolic blood pressure of less than 90 mm Hg) after a 2-L fluid bolus, with subsequent vasopressor dependence. Vasopressor dependence in the study was defined as continuous infusion of norepinephrine or epinephrine, or of dopamine at 5 mcg/kg per minute or greater.
The final criterion for inclusion was lactate greater than 3 mmol/dL after the initial fluid bolus. “Interestingly, if you change that 3 to 2, this is very similar to the current definition of septic shock,” said Dr. Donnino.
The primary endpoint of the study was median lactate level at 24 hours, with secondary endpoints of lactate change at 24 hours, shock reversal, and mortality. Adverse events and mortality were the safety endpoints.
Baseline characteristics were similar for both study arms, except that the thiamine group had a higher proportion of patients with diabetes than the placebo group (17/43 [40%] vs. 6/45 [13%]).
The study excluded cases in which lactic acidosis might be due to reasons other than septic shock, such as recent seizures, use of medications that can cause lactic acidosis, ischemia, and carbon monoxide poisoning. Patients who had another indication for thiamine administration, such as those in acute alcohol withdrawal, were excluded as well.
Some data analysis was hampered by the high in-hospital mortality rate of 43%. Also, the study involved a target population of critically ill patients, drawn mostly from a single center.
Bringing the discussion to the real world, moderator Dr. Timothy Buchman, director of the critical care center at Emory University, Atlanta, asked, “Today, when you see a patient in sepsis, do you routinely give thiamine?”
Dr. Donnino responded, “When I see someone in septic shock with a persistent lactic acidosis who I consider to be in a risk category, my clinical practice is to give them thiamine now. I’m not necessarily saying that I advocate that to the wider critical care community based on our data, but that’s just based on my experience and what I’ve seen over the years.”
The study was funded by the National Institutes of Health. Dr. Donnino and his coauthors reported no relevant financial disclolsures.
On Twitter @karioakes
AT THE CRITICAL CARE CONGRESS
Key clinical point: Thiamine supplementation reduced kidney failure and improved survival for thiamine-deficient patients in septic shock.
Major finding: For patients who were thiamine deficient and in septic shock, thiamine replacement significantly reduced lactate at 24 hours (median, 2.1 mmol/L vs. 3.1 for placebo, P = .03).
Data source: A randomized, double-blind, placebo-controlled clinical trial of intravenous thiamine administration for 88 patients in septic shock.
Disclosures: The study was funded by the National Institutes of Health. Dr. Donnino and his coauthors reported no relevant financial disclosures.
New prediction tool forecasts long-term ICU outcomes for very elderly
ORLANDO – A new clinical prediction rule correlates well with performance status at 1 year after ICU hospitalization in patients over age 80.
Illness severity, comorbidities, baseline frailty, a primary diagnosis of stroke, and being male were all predictors of poor performance status at 1 year. A primary diagnosis of emergency coronary artery bypass grafting or valve replacement, a high baseline performance status, and being married were associated with good performance status at 1 year. The c-statistic for the model, a standard indicator of predictive power, was 0.811, a figure that indicates good predictive ability.
The findings from the REALISTIC 80 (Realities, Expectations ,and Attitudes to Life Support Technologies in Intensive Care for Octogenarians) study of 17 patient and illness characteristics allowed Dr. Daren Heyland, professor of medicine and epidemiology at Queen’s University, Kingston, Ont., and his coinvestigators in the Canadian Critical Care Trials Group (CCCTG), to conclude that eight factors were most predictive of performance status at 12 months for ICU patients aged 80 and over. REALISTIC 80 is a CCCTG project.
The values for the predictors are derived from responses to an online guided questionnaire called the ICU Workbook. The questionnaire is completed by patients’ family members or surrogates, and the responses are used to calculate the values that constitute the clinical prediction rule’s components.
Gathering this information may help health care providers and family members in end-of-life decision making, said Dr. Heyland. “For the very elderly, it is plausible that poor communication and decision making lead to overutilization of ICU resources and poor-quality end-of-life care,” he said. “Hopefully, with these strategies, we’ll improve clinical decision making and improve the quality of end-of-life care we provide for our older patients,” said Dr. Heyland, who is also director of CARENET, which hosts the online guided questionnaire and is an affiliation of Canadian researchers focused on end-of-life care. He spoke at the Society of Critical Care Medicine’s Critical Care Congress.
REALISTIC 80 enrolled 434 patients, aged 80-100 years (mean age, 84.6) who were admitted to ICUs at participating institutions.
Previous European and U.S. studies have shown an ICU mortality of 30%-35%, and an overall mortality rate of 60%-70% in the 12 months following ICU admission. In those studies, illness severity most strongly predicted short-term survival, and comorbidities best predicted long-term survival.
The primary outcome measure of REALISTIC 80 was the 12-month survival and health-related quality of life; “recovery from critical illness” was defined as a Palliative Performance Scale (PPS) score of greater than or equal to 60% at 12 months. Patients scoring at 60% on the 0%-100% scale of this functional status measure may have reduced ambulation, be unable to engage in housework or hobbies, have significant disease, need assistance, and be confused at times. An advantage of this scale, said Dr. Heyland, is that it eliminates survivorship bias in analyzing data, since a score of 0 is assigned to individuals who die.
About 50% of patients had died by 12 months; about 21% were alive, with a reduced health status below the threshold of 60 on the PPS; and about 29% were alive, with a PPS score above the predetermined quality of life threshold.
Dr. Heyland acknowledged that the study lost a significant number of participants – about 17% – to follow-up. The predictive model was derived from completed cases, and a sensitivity analysis using imputed data for missing patients showed that it retained its predictive value.
Dr. Heyland said the presence of advance directives didn’t appear to affect outcomes. “We subsequently in a different analysis showed that whether they had [a directive] or not, did not affect subsequent process or outcome of care in the ICU,” he said.
Dying in the ICU after days of mechanical ventilation or surviving with very low performance status “doesn’t sound like good quality of life to me, and it illustrates the challenge we have as clinicians in getting to what’s best for patients,” said Dr. Heyland. “Hopefully, prediction models will help, as well as better elicitation of authentic values and preferences from patients.”
The study was funded by the Canadian Institutes of Health Research and conducted under the auspices of the CCCTG and CARENET. The study investigators reported no other relevant financial disclosures.
On Twitter @karioakes
ORLANDO – A new clinical prediction rule correlates well with performance status at 1 year after ICU hospitalization in patients over age 80.
Illness severity, comorbidities, baseline frailty, a primary diagnosis of stroke, and being male were all predictors of poor performance status at 1 year. A primary diagnosis of emergency coronary artery bypass grafting or valve replacement, a high baseline performance status, and being married were associated with good performance status at 1 year. The c-statistic for the model, a standard indicator of predictive power, was 0.811, a figure that indicates good predictive ability.
The findings from the REALISTIC 80 (Realities, Expectations ,and Attitudes to Life Support Technologies in Intensive Care for Octogenarians) study of 17 patient and illness characteristics allowed Dr. Daren Heyland, professor of medicine and epidemiology at Queen’s University, Kingston, Ont., and his coinvestigators in the Canadian Critical Care Trials Group (CCCTG), to conclude that eight factors were most predictive of performance status at 12 months for ICU patients aged 80 and over. REALISTIC 80 is a CCCTG project.
The values for the predictors are derived from responses to an online guided questionnaire called the ICU Workbook. The questionnaire is completed by patients’ family members or surrogates, and the responses are used to calculate the values that constitute the clinical prediction rule’s components.
Gathering this information may help health care providers and family members in end-of-life decision making, said Dr. Heyland. “For the very elderly, it is plausible that poor communication and decision making lead to overutilization of ICU resources and poor-quality end-of-life care,” he said. “Hopefully, with these strategies, we’ll improve clinical decision making and improve the quality of end-of-life care we provide for our older patients,” said Dr. Heyland, who is also director of CARENET, which hosts the online guided questionnaire and is an affiliation of Canadian researchers focused on end-of-life care. He spoke at the Society of Critical Care Medicine’s Critical Care Congress.
REALISTIC 80 enrolled 434 patients, aged 80-100 years (mean age, 84.6) who were admitted to ICUs at participating institutions.
Previous European and U.S. studies have shown an ICU mortality of 30%-35%, and an overall mortality rate of 60%-70% in the 12 months following ICU admission. In those studies, illness severity most strongly predicted short-term survival, and comorbidities best predicted long-term survival.
The primary outcome measure of REALISTIC 80 was the 12-month survival and health-related quality of life; “recovery from critical illness” was defined as a Palliative Performance Scale (PPS) score of greater than or equal to 60% at 12 months. Patients scoring at 60% on the 0%-100% scale of this functional status measure may have reduced ambulation, be unable to engage in housework or hobbies, have significant disease, need assistance, and be confused at times. An advantage of this scale, said Dr. Heyland, is that it eliminates survivorship bias in analyzing data, since a score of 0 is assigned to individuals who die.
About 50% of patients had died by 12 months; about 21% were alive, with a reduced health status below the threshold of 60 on the PPS; and about 29% were alive, with a PPS score above the predetermined quality of life threshold.
Dr. Heyland acknowledged that the study lost a significant number of participants – about 17% – to follow-up. The predictive model was derived from completed cases, and a sensitivity analysis using imputed data for missing patients showed that it retained its predictive value.
Dr. Heyland said the presence of advance directives didn’t appear to affect outcomes. “We subsequently in a different analysis showed that whether they had [a directive] or not, did not affect subsequent process or outcome of care in the ICU,” he said.
Dying in the ICU after days of mechanical ventilation or surviving with very low performance status “doesn’t sound like good quality of life to me, and it illustrates the challenge we have as clinicians in getting to what’s best for patients,” said Dr. Heyland. “Hopefully, prediction models will help, as well as better elicitation of authentic values and preferences from patients.”
The study was funded by the Canadian Institutes of Health Research and conducted under the auspices of the CCCTG and CARENET. The study investigators reported no other relevant financial disclosures.
On Twitter @karioakes
ORLANDO – A new clinical prediction rule correlates well with performance status at 1 year after ICU hospitalization in patients over age 80.
Illness severity, comorbidities, baseline frailty, a primary diagnosis of stroke, and being male were all predictors of poor performance status at 1 year. A primary diagnosis of emergency coronary artery bypass grafting or valve replacement, a high baseline performance status, and being married were associated with good performance status at 1 year. The c-statistic for the model, a standard indicator of predictive power, was 0.811, a figure that indicates good predictive ability.
The findings from the REALISTIC 80 (Realities, Expectations ,and Attitudes to Life Support Technologies in Intensive Care for Octogenarians) study of 17 patient and illness characteristics allowed Dr. Daren Heyland, professor of medicine and epidemiology at Queen’s University, Kingston, Ont., and his coinvestigators in the Canadian Critical Care Trials Group (CCCTG), to conclude that eight factors were most predictive of performance status at 12 months for ICU patients aged 80 and over. REALISTIC 80 is a CCCTG project.
The values for the predictors are derived from responses to an online guided questionnaire called the ICU Workbook. The questionnaire is completed by patients’ family members or surrogates, and the responses are used to calculate the values that constitute the clinical prediction rule’s components.
Gathering this information may help health care providers and family members in end-of-life decision making, said Dr. Heyland. “For the very elderly, it is plausible that poor communication and decision making lead to overutilization of ICU resources and poor-quality end-of-life care,” he said. “Hopefully, with these strategies, we’ll improve clinical decision making and improve the quality of end-of-life care we provide for our older patients,” said Dr. Heyland, who is also director of CARENET, which hosts the online guided questionnaire and is an affiliation of Canadian researchers focused on end-of-life care. He spoke at the Society of Critical Care Medicine’s Critical Care Congress.
REALISTIC 80 enrolled 434 patients, aged 80-100 years (mean age, 84.6) who were admitted to ICUs at participating institutions.
Previous European and U.S. studies have shown an ICU mortality of 30%-35%, and an overall mortality rate of 60%-70% in the 12 months following ICU admission. In those studies, illness severity most strongly predicted short-term survival, and comorbidities best predicted long-term survival.
The primary outcome measure of REALISTIC 80 was the 12-month survival and health-related quality of life; “recovery from critical illness” was defined as a Palliative Performance Scale (PPS) score of greater than or equal to 60% at 12 months. Patients scoring at 60% on the 0%-100% scale of this functional status measure may have reduced ambulation, be unable to engage in housework or hobbies, have significant disease, need assistance, and be confused at times. An advantage of this scale, said Dr. Heyland, is that it eliminates survivorship bias in analyzing data, since a score of 0 is assigned to individuals who die.
About 50% of patients had died by 12 months; about 21% were alive, with a reduced health status below the threshold of 60 on the PPS; and about 29% were alive, with a PPS score above the predetermined quality of life threshold.
Dr. Heyland acknowledged that the study lost a significant number of participants – about 17% – to follow-up. The predictive model was derived from completed cases, and a sensitivity analysis using imputed data for missing patients showed that it retained its predictive value.
Dr. Heyland said the presence of advance directives didn’t appear to affect outcomes. “We subsequently in a different analysis showed that whether they had [a directive] or not, did not affect subsequent process or outcome of care in the ICU,” he said.
Dying in the ICU after days of mechanical ventilation or surviving with very low performance status “doesn’t sound like good quality of life to me, and it illustrates the challenge we have as clinicians in getting to what’s best for patients,” said Dr. Heyland. “Hopefully, prediction models will help, as well as better elicitation of authentic values and preferences from patients.”
The study was funded by the Canadian Institutes of Health Research and conducted under the auspices of the CCCTG and CARENET. The study investigators reported no other relevant financial disclosures.
On Twitter @karioakes
AT THE CRITICAL CARE CONGRESS
Key clinical point: Eight patient and illness factors were associated with long-term outcomes for ICU patients over age 80.
Major finding: Illness severity, baseline frailty, and comorbidities were associated with lower performance status at 12 months.
Data source: A multicenter study examining 17 patient and illness factors for 434 patients aged 80 and older, admitted to ICUs and followed for 12 months.
Disclosures: The study was funded by the Canadian Institutes of Health Research and conducted under the auspices of the CCCTG and CARENET. The study investigators reported no relevant financial disclosures.
Periop statins don’t prevent acute kidney injury after cardiac surgery
ORLANDO – Statins administered perioperatively offered no protection against acute kidney injury following cardiac surgery, according to new results of a 5-year randomized clinical trial.
The findings held true whether or not patients were naive to statins; serum creatinine levels actually increased significantly more for statin-naive patients given atorvastatin than those given placebo.
The study was stopped early for patients naive to statins because increased acute kidney injury was seen in those patients who had chronic kidney disease (eGFR less than 60 mL/min/1.73 m2), and was subsequently stopped early for futility for all patients.
“De novo initiation of daily perioperative atorvastatin treatment did not reduce the incidence of AKI or reduce the increase in serum creatinine concentration associated with cardiac surgery,” wrote Dr. Frederic T. Billings IV, professor of medicine at Vanderbilt University, Nashville, Tenn., and his collaborators. The findings (JAMA 2016 Feb 23. doi: 10.1001/jama.2016.0548) were published concurrently with his presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.
In what Dr. Phil B. Fontanarosa, executive editor of JAMA and comoderator of the late-breaking trials session at the meeting, described as “really an elegant clinical trial,” Dr. Billings and his collaborators enrolled 615 patients over 5 years at Vanderbilt University Medical Center.
Patients undergoing elective coronary artery bypass grafting, valvular heart surgery, or ascending aortic surgery were eligible. Patients were excluded if they had prior statin intolerance, acute coronary syndrome, or liver dysfunction; were taking potent CYP3A4 inhibitors or cyclosporine; were receiving renal replacement therapy or had a kidney transplant; or were pregnant.
Both patients currently on a statin and patients naive to statins were recruited. Statin-naive patients received 80 mg atorvastatin the day before surgery, and then 40 mg of atorvastatin on the day of surgery and daily following surgery, or a matched placebo regimen.
Patients who were already on a statin received the study drug only on days that they would not have received a statin if treated according to the current standard of care. It was deemed unethical to allow those patients to receive placebo during and after surgery, since observational studies suggested that doing so might increase their potential for AKI.
For those patients already on a statin, this meant that they stayed on their usual regimen until the day of surgery, and then were randomized to receive either 80 mg of atorvastatin on the day of surgery and 40 mg of atorvastatin the day after surgery, or a matching placebo regimen.
For both groups, the study drug was given at least 3 hours before surgery on the day of surgery.
Randomization was stratified for prior statin use, for chronic kidney disease, and by history of diabetes. The 199 patients naive to statins and the 416 already on a statin were similar in demographic and health characteristics. Median age was 67 years, 188 (30.6%) were women; 202 participants (32.8%) had diabetes.
The primary outcome measure was diagnosis of AKI, defined as an increase of 0.3 mg/dL in serum creatinine, or beginning renal replacement therapy within 48 hours of surgery. Baseline serum creatinine was measured no more than 7 days prior to surgery.
AKI occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall (P = .75). For those naive to statins, 21.6% of the atorvastatin group and 13.4% of the placebo group developed AKI (P = .15). Overall, 179 enrolled patients had CKD, and the incidence of AKI did not significantly differ in the atorvastatin and the placebo arms of this subgroup.
The subpopulation of participants with CKD who were statin naive (n = 36), however, saw an increased incidence of AKI with atorvastatin compared to placebo. AKI occurred in 9 of 17 patients (52.9%) given atorvastatin, and in 3 of 19 (15.8%) given placebo group (RR, 3.35[95% confidence interval 0.12 to 10.05]; P = .03). “It should be noted that the number of patients in this subgroup was particularly small, leading to a wide confidence interval and an increased chance of type 1 error,” said Dr. Billings.
Secondary outcome measures were maximum increase in creatinine concentration from baseline through postop day 2, delirium in the ICU, degree of myocardial injury, and incidence of postoperative pneumonia, atrial fibrillation, or stroke. Perioperative atorvastatin administration did not affect any of these endpoints.
The safety analysis showed no indications of increased risk of skeletal muscle or liver injury with perioperative atorvastatin use.
In the real world, “Most patients presenting for cardiac surgery … are already taking statins, and in the current study there was little evidence that continuation or withdrawal from statin treatment on the day of surgery and postoperative day 1 affects AKI,” wrote Dr. Billings and his coauthors.
Study limitations included its single-center design, and the use of AKI criteria that may not be sensitive to late-developing AKI. Also, for enrolled patients who were already on statins, statin exposure was not reduced in comparison with usual care.
After the presentation, Dr. Billings reported that the researchers also collected information about other biomarkers that may signal AKI, including IgM. He and his collaborators plan later publication of those data after a full analysis.
The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.
On Twitter @karioakes
ORLANDO – Statins administered perioperatively offered no protection against acute kidney injury following cardiac surgery, according to new results of a 5-year randomized clinical trial.
The findings held true whether or not patients were naive to statins; serum creatinine levels actually increased significantly more for statin-naive patients given atorvastatin than those given placebo.
The study was stopped early for patients naive to statins because increased acute kidney injury was seen in those patients who had chronic kidney disease (eGFR less than 60 mL/min/1.73 m2), and was subsequently stopped early for futility for all patients.
“De novo initiation of daily perioperative atorvastatin treatment did not reduce the incidence of AKI or reduce the increase in serum creatinine concentration associated with cardiac surgery,” wrote Dr. Frederic T. Billings IV, professor of medicine at Vanderbilt University, Nashville, Tenn., and his collaborators. The findings (JAMA 2016 Feb 23. doi: 10.1001/jama.2016.0548) were published concurrently with his presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.
In what Dr. Phil B. Fontanarosa, executive editor of JAMA and comoderator of the late-breaking trials session at the meeting, described as “really an elegant clinical trial,” Dr. Billings and his collaborators enrolled 615 patients over 5 years at Vanderbilt University Medical Center.
Patients undergoing elective coronary artery bypass grafting, valvular heart surgery, or ascending aortic surgery were eligible. Patients were excluded if they had prior statin intolerance, acute coronary syndrome, or liver dysfunction; were taking potent CYP3A4 inhibitors or cyclosporine; were receiving renal replacement therapy or had a kidney transplant; or were pregnant.
Both patients currently on a statin and patients naive to statins were recruited. Statin-naive patients received 80 mg atorvastatin the day before surgery, and then 40 mg of atorvastatin on the day of surgery and daily following surgery, or a matched placebo regimen.
Patients who were already on a statin received the study drug only on days that they would not have received a statin if treated according to the current standard of care. It was deemed unethical to allow those patients to receive placebo during and after surgery, since observational studies suggested that doing so might increase their potential for AKI.
For those patients already on a statin, this meant that they stayed on their usual regimen until the day of surgery, and then were randomized to receive either 80 mg of atorvastatin on the day of surgery and 40 mg of atorvastatin the day after surgery, or a matching placebo regimen.
For both groups, the study drug was given at least 3 hours before surgery on the day of surgery.
Randomization was stratified for prior statin use, for chronic kidney disease, and by history of diabetes. The 199 patients naive to statins and the 416 already on a statin were similar in demographic and health characteristics. Median age was 67 years, 188 (30.6%) were women; 202 participants (32.8%) had diabetes.
The primary outcome measure was diagnosis of AKI, defined as an increase of 0.3 mg/dL in serum creatinine, or beginning renal replacement therapy within 48 hours of surgery. Baseline serum creatinine was measured no more than 7 days prior to surgery.
AKI occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall (P = .75). For those naive to statins, 21.6% of the atorvastatin group and 13.4% of the placebo group developed AKI (P = .15). Overall, 179 enrolled patients had CKD, and the incidence of AKI did not significantly differ in the atorvastatin and the placebo arms of this subgroup.
The subpopulation of participants with CKD who were statin naive (n = 36), however, saw an increased incidence of AKI with atorvastatin compared to placebo. AKI occurred in 9 of 17 patients (52.9%) given atorvastatin, and in 3 of 19 (15.8%) given placebo group (RR, 3.35[95% confidence interval 0.12 to 10.05]; P = .03). “It should be noted that the number of patients in this subgroup was particularly small, leading to a wide confidence interval and an increased chance of type 1 error,” said Dr. Billings.
Secondary outcome measures were maximum increase in creatinine concentration from baseline through postop day 2, delirium in the ICU, degree of myocardial injury, and incidence of postoperative pneumonia, atrial fibrillation, or stroke. Perioperative atorvastatin administration did not affect any of these endpoints.
The safety analysis showed no indications of increased risk of skeletal muscle or liver injury with perioperative atorvastatin use.
In the real world, “Most patients presenting for cardiac surgery … are already taking statins, and in the current study there was little evidence that continuation or withdrawal from statin treatment on the day of surgery and postoperative day 1 affects AKI,” wrote Dr. Billings and his coauthors.
Study limitations included its single-center design, and the use of AKI criteria that may not be sensitive to late-developing AKI. Also, for enrolled patients who were already on statins, statin exposure was not reduced in comparison with usual care.
After the presentation, Dr. Billings reported that the researchers also collected information about other biomarkers that may signal AKI, including IgM. He and his collaborators plan later publication of those data after a full analysis.
The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.
On Twitter @karioakes
ORLANDO – Statins administered perioperatively offered no protection against acute kidney injury following cardiac surgery, according to new results of a 5-year randomized clinical trial.
The findings held true whether or not patients were naive to statins; serum creatinine levels actually increased significantly more for statin-naive patients given atorvastatin than those given placebo.
The study was stopped early for patients naive to statins because increased acute kidney injury was seen in those patients who had chronic kidney disease (eGFR less than 60 mL/min/1.73 m2), and was subsequently stopped early for futility for all patients.
“De novo initiation of daily perioperative atorvastatin treatment did not reduce the incidence of AKI or reduce the increase in serum creatinine concentration associated with cardiac surgery,” wrote Dr. Frederic T. Billings IV, professor of medicine at Vanderbilt University, Nashville, Tenn., and his collaborators. The findings (JAMA 2016 Feb 23. doi: 10.1001/jama.2016.0548) were published concurrently with his presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.
In what Dr. Phil B. Fontanarosa, executive editor of JAMA and comoderator of the late-breaking trials session at the meeting, described as “really an elegant clinical trial,” Dr. Billings and his collaborators enrolled 615 patients over 5 years at Vanderbilt University Medical Center.
Patients undergoing elective coronary artery bypass grafting, valvular heart surgery, or ascending aortic surgery were eligible. Patients were excluded if they had prior statin intolerance, acute coronary syndrome, or liver dysfunction; were taking potent CYP3A4 inhibitors or cyclosporine; were receiving renal replacement therapy or had a kidney transplant; or were pregnant.
Both patients currently on a statin and patients naive to statins were recruited. Statin-naive patients received 80 mg atorvastatin the day before surgery, and then 40 mg of atorvastatin on the day of surgery and daily following surgery, or a matched placebo regimen.
Patients who were already on a statin received the study drug only on days that they would not have received a statin if treated according to the current standard of care. It was deemed unethical to allow those patients to receive placebo during and after surgery, since observational studies suggested that doing so might increase their potential for AKI.
For those patients already on a statin, this meant that they stayed on their usual regimen until the day of surgery, and then were randomized to receive either 80 mg of atorvastatin on the day of surgery and 40 mg of atorvastatin the day after surgery, or a matching placebo regimen.
For both groups, the study drug was given at least 3 hours before surgery on the day of surgery.
Randomization was stratified for prior statin use, for chronic kidney disease, and by history of diabetes. The 199 patients naive to statins and the 416 already on a statin were similar in demographic and health characteristics. Median age was 67 years, 188 (30.6%) were women; 202 participants (32.8%) had diabetes.
The primary outcome measure was diagnosis of AKI, defined as an increase of 0.3 mg/dL in serum creatinine, or beginning renal replacement therapy within 48 hours of surgery. Baseline serum creatinine was measured no more than 7 days prior to surgery.
AKI occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall (P = .75). For those naive to statins, 21.6% of the atorvastatin group and 13.4% of the placebo group developed AKI (P = .15). Overall, 179 enrolled patients had CKD, and the incidence of AKI did not significantly differ in the atorvastatin and the placebo arms of this subgroup.
The subpopulation of participants with CKD who were statin naive (n = 36), however, saw an increased incidence of AKI with atorvastatin compared to placebo. AKI occurred in 9 of 17 patients (52.9%) given atorvastatin, and in 3 of 19 (15.8%) given placebo group (RR, 3.35[95% confidence interval 0.12 to 10.05]; P = .03). “It should be noted that the number of patients in this subgroup was particularly small, leading to a wide confidence interval and an increased chance of type 1 error,” said Dr. Billings.
Secondary outcome measures were maximum increase in creatinine concentration from baseline through postop day 2, delirium in the ICU, degree of myocardial injury, and incidence of postoperative pneumonia, atrial fibrillation, or stroke. Perioperative atorvastatin administration did not affect any of these endpoints.
The safety analysis showed no indications of increased risk of skeletal muscle or liver injury with perioperative atorvastatin use.
In the real world, “Most patients presenting for cardiac surgery … are already taking statins, and in the current study there was little evidence that continuation or withdrawal from statin treatment on the day of surgery and postoperative day 1 affects AKI,” wrote Dr. Billings and his coauthors.
Study limitations included its single-center design, and the use of AKI criteria that may not be sensitive to late-developing AKI. Also, for enrolled patients who were already on statins, statin exposure was not reduced in comparison with usual care.
After the presentation, Dr. Billings reported that the researchers also collected information about other biomarkers that may signal AKI, including IgM. He and his collaborators plan later publication of those data after a full analysis.
The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.
On Twitter @karioakes
AT THE CRITICAL CARE CONGRESS
Key clinical point: Perioperative atorvastatin did not protect against acute kidney injury after cardiac surgery.
Major finding: Acute kidney injury occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall, a nonsignificant difference (P = .75).
Data source: Randomized, double-blinded, placebo-controlled trial of 615 adults who underwent cardiac surgery.
Disclosures: The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.
ICU care bundle cut delirium, in-hospital deaths
AT THE CRITICAL CARE CONGRESS
ORLANDO – Implementing an ICU care plan got patients moving and breathing on their own sooner. The interventions resulted in significantly less delirium and better in-hospital survival in 6,000 patients treated at seven community hospitals, according to data presented at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.
The care bundle focused on minimizing sedation and maximizing patient mobilization. For each 10% increase in compliance with the care plan, community ICUs saw a 15% increase in delirium-free ICU days. In-hospital survival also increased by 15% for every 10% increase in implementation.
The ICU Liberation project set forward the ABCDEF care bundle to operationalize the Society for Critical Care Medicine (SCCM) 2012 guidelines regarding pain, agitation, and delirium in the ICU.
“It’s never quite clear whether guidelines, which are developed from randomized controlled trials in academic university hospitals, can be implemented in the community hospital setting. And as we know, the majority of critical care in our country is provided in the community hospital setting,” said Mary Ann Barnes-Daly, an RN who is the regional clinical initiative lead for ICU Liberation at Sutter Health in Sacramento, Calif.
The care bundle calls for all ICU patients to have daily assessments for pain and delirium, spontaneous awakening and breathing trials, minimal sedation, early mobilization and exercise, and family involvement as part of the care team.
A dedicated RN, whose sole responsibility was to implement the ICU Liberation program, led the on-site teams. Other team members were an administrative RN, a pharmacist, a physical therapist, a respiratory care practitioner, and an ICU physician. In some hospitals, the physician was an intensivist, while in others, a hospitalist provided ICU care.
“We provided clinical education, and more importantly, interprofessional team education, where the teams learned to work together,” said Ms. Barnes-Daly. Rounds were audited and audit results, along with ongoing data collection and reporting, were the basis for ongoing reporting and process improvement.
The mantra for care bundle implementation was “every patient, every day,” said Ms. Barnes-Daly. Patient exclusions were based on safety and included such factors as hemodynamic, respiratory, or neurologic instability; open abdomen; active alcohol withdrawal; and new coronary ischemia.
Altogether, 6,064 patients were involved in the program; about one in four patients received mechanical ventilation during their stay. When patients were mechanically ventilated, all aspects of the care bundle were to be implemented. When patients were not receiving mechanical ventilation, only four aspects of the bundle applied and were measured. Overall, patients were mechanically ventilated for about 20% of the days observed.
Compliance with the care bundle was measured in two ways, said Ms. Barnes-Daly: One analysis was all-or-none, measuring the proportion of a patient’s ICU stay for which all applicable bundle elements were implemented. The other measure allowed partial compliance; dose compliance was calculated by averaging the proportion of care bundle compliance for each day over the patient’s ICU stay. This second analysis proved more sensitive in assessing the effects of the care bundle.
A dose-response ratio was noted between the number of delirium-free and coma-free days and the number of care bundle components delivered (P less than .001). Similarly, hospital survival also increased as bundle delivery increased, with each 10% increase in compliance associated with a 15% increase in hospital survival (P less than .001). When palliative care patients were removed from data analysis, hospital survival increased by 23% with each 10% increase in bundle compliance, said Ms. Barnes-Daly.
The study’s strengths include “the large sample size, and the fact that we adjusted for age, Apache score, and mechanical ventilation,” said Ms. Barnes-Daly. The limitations are that this was not a randomized controlled trial, and data were initially collected by the nurse team leader. Data collection was subsequently switched to the electronic ICU team.
The QI program was sponsored by the Society for Critical Care Medicine, and conducted at Sutter Health community Hospitals. Ms. Barnes-Daly reported receiving honoraria from the Society for Critical Care Medicine.
On Twitter @karioakes
AT THE CRITICAL CARE CONGRESS
ORLANDO – Implementing an ICU care plan got patients moving and breathing on their own sooner. The interventions resulted in significantly less delirium and better in-hospital survival in 6,000 patients treated at seven community hospitals, according to data presented at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.
The care bundle focused on minimizing sedation and maximizing patient mobilization. For each 10% increase in compliance with the care plan, community ICUs saw a 15% increase in delirium-free ICU days. In-hospital survival also increased by 15% for every 10% increase in implementation.
The ICU Liberation project set forward the ABCDEF care bundle to operationalize the Society for Critical Care Medicine (SCCM) 2012 guidelines regarding pain, agitation, and delirium in the ICU.
“It’s never quite clear whether guidelines, which are developed from randomized controlled trials in academic university hospitals, can be implemented in the community hospital setting. And as we know, the majority of critical care in our country is provided in the community hospital setting,” said Mary Ann Barnes-Daly, an RN who is the regional clinical initiative lead for ICU Liberation at Sutter Health in Sacramento, Calif.
The care bundle calls for all ICU patients to have daily assessments for pain and delirium, spontaneous awakening and breathing trials, minimal sedation, early mobilization and exercise, and family involvement as part of the care team.
A dedicated RN, whose sole responsibility was to implement the ICU Liberation program, led the on-site teams. Other team members were an administrative RN, a pharmacist, a physical therapist, a respiratory care practitioner, and an ICU physician. In some hospitals, the physician was an intensivist, while in others, a hospitalist provided ICU care.
“We provided clinical education, and more importantly, interprofessional team education, where the teams learned to work together,” said Ms. Barnes-Daly. Rounds were audited and audit results, along with ongoing data collection and reporting, were the basis for ongoing reporting and process improvement.
The mantra for care bundle implementation was “every patient, every day,” said Ms. Barnes-Daly. Patient exclusions were based on safety and included such factors as hemodynamic, respiratory, or neurologic instability; open abdomen; active alcohol withdrawal; and new coronary ischemia.
Altogether, 6,064 patients were involved in the program; about one in four patients received mechanical ventilation during their stay. When patients were mechanically ventilated, all aspects of the care bundle were to be implemented. When patients were not receiving mechanical ventilation, only four aspects of the bundle applied and were measured. Overall, patients were mechanically ventilated for about 20% of the days observed.
Compliance with the care bundle was measured in two ways, said Ms. Barnes-Daly: One analysis was all-or-none, measuring the proportion of a patient’s ICU stay for which all applicable bundle elements were implemented. The other measure allowed partial compliance; dose compliance was calculated by averaging the proportion of care bundle compliance for each day over the patient’s ICU stay. This second analysis proved more sensitive in assessing the effects of the care bundle.
A dose-response ratio was noted between the number of delirium-free and coma-free days and the number of care bundle components delivered (P less than .001). Similarly, hospital survival also increased as bundle delivery increased, with each 10% increase in compliance associated with a 15% increase in hospital survival (P less than .001). When palliative care patients were removed from data analysis, hospital survival increased by 23% with each 10% increase in bundle compliance, said Ms. Barnes-Daly.
The study’s strengths include “the large sample size, and the fact that we adjusted for age, Apache score, and mechanical ventilation,” said Ms. Barnes-Daly. The limitations are that this was not a randomized controlled trial, and data were initially collected by the nurse team leader. Data collection was subsequently switched to the electronic ICU team.
The QI program was sponsored by the Society for Critical Care Medicine, and conducted at Sutter Health community Hospitals. Ms. Barnes-Daly reported receiving honoraria from the Society for Critical Care Medicine.
On Twitter @karioakes
AT THE CRITICAL CARE CONGRESS
ORLANDO – Implementing an ICU care plan got patients moving and breathing on their own sooner. The interventions resulted in significantly less delirium and better in-hospital survival in 6,000 patients treated at seven community hospitals, according to data presented at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.
The care bundle focused on minimizing sedation and maximizing patient mobilization. For each 10% increase in compliance with the care plan, community ICUs saw a 15% increase in delirium-free ICU days. In-hospital survival also increased by 15% for every 10% increase in implementation.
The ICU Liberation project set forward the ABCDEF care bundle to operationalize the Society for Critical Care Medicine (SCCM) 2012 guidelines regarding pain, agitation, and delirium in the ICU.
“It’s never quite clear whether guidelines, which are developed from randomized controlled trials in academic university hospitals, can be implemented in the community hospital setting. And as we know, the majority of critical care in our country is provided in the community hospital setting,” said Mary Ann Barnes-Daly, an RN who is the regional clinical initiative lead for ICU Liberation at Sutter Health in Sacramento, Calif.
The care bundle calls for all ICU patients to have daily assessments for pain and delirium, spontaneous awakening and breathing trials, minimal sedation, early mobilization and exercise, and family involvement as part of the care team.
A dedicated RN, whose sole responsibility was to implement the ICU Liberation program, led the on-site teams. Other team members were an administrative RN, a pharmacist, a physical therapist, a respiratory care practitioner, and an ICU physician. In some hospitals, the physician was an intensivist, while in others, a hospitalist provided ICU care.
“We provided clinical education, and more importantly, interprofessional team education, where the teams learned to work together,” said Ms. Barnes-Daly. Rounds were audited and audit results, along with ongoing data collection and reporting, were the basis for ongoing reporting and process improvement.
The mantra for care bundle implementation was “every patient, every day,” said Ms. Barnes-Daly. Patient exclusions were based on safety and included such factors as hemodynamic, respiratory, or neurologic instability; open abdomen; active alcohol withdrawal; and new coronary ischemia.
Altogether, 6,064 patients were involved in the program; about one in four patients received mechanical ventilation during their stay. When patients were mechanically ventilated, all aspects of the care bundle were to be implemented. When patients were not receiving mechanical ventilation, only four aspects of the bundle applied and were measured. Overall, patients were mechanically ventilated for about 20% of the days observed.
Compliance with the care bundle was measured in two ways, said Ms. Barnes-Daly: One analysis was all-or-none, measuring the proportion of a patient’s ICU stay for which all applicable bundle elements were implemented. The other measure allowed partial compliance; dose compliance was calculated by averaging the proportion of care bundle compliance for each day over the patient’s ICU stay. This second analysis proved more sensitive in assessing the effects of the care bundle.
A dose-response ratio was noted between the number of delirium-free and coma-free days and the number of care bundle components delivered (P less than .001). Similarly, hospital survival also increased as bundle delivery increased, with each 10% increase in compliance associated with a 15% increase in hospital survival (P less than .001). When palliative care patients were removed from data analysis, hospital survival increased by 23% with each 10% increase in bundle compliance, said Ms. Barnes-Daly.
The study’s strengths include “the large sample size, and the fact that we adjusted for age, Apache score, and mechanical ventilation,” said Ms. Barnes-Daly. The limitations are that this was not a randomized controlled trial, and data were initially collected by the nurse team leader. Data collection was subsequently switched to the electronic ICU team.
The QI program was sponsored by the Society for Critical Care Medicine, and conducted at Sutter Health community Hospitals. Ms. Barnes-Daly reported receiving honoraria from the Society for Critical Care Medicine.
On Twitter @karioakes
Key clinical point: Delirium and in-hospital deaths were reduced with a comprehensive ICU care bundle.
Major finding: For each 10% increase in care bundle implementation, in-hospital deaths and days of delirium decreased by 15%.
Data source: Quality improvement program involving 6,064 ICU patients at seven community hospitals.
Disclosures: The QI program was sponsored by the Society for Critical Care Medicine, and conducted at Sutter Health community hospitals. Ms. Barnes-Daly reported receiving honoraria from the Society for Critical Care Medicine.
LUNG SAFE: Globally, ARDS is under-recognized, undertreated
ORLANDO – Many patients meeting the criteria for acute respiratory distress syndrome (ARDS) went unrecognized in a global sample of ICU patients, and those ARDS patients did not receive adjusted ventilator management or positioning and pharmacologic adjunctive treatments, based on the results of the LUNG SAFE study.
Enrolling nearly 30,000 patients in 50 countries on five continents, the LUNG SAFE study (Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure) looked for real-world answers to whether and how patients with ARDS are treated. The LUNG SAFE results were published concurrently with the presentation of results in a late-breaking session at the Critical Care Congress, sponsored by the Society of Critical Care Medicine (JAMA. 2016;315[8]:759-61). The first author is Dr. Giacomo Bellani, professor of medicine at the University of Milan-Bicocca, Monza, Italy, and Dr. John Laffey, professor of anesthesia, critical care, and physiology at the University of Toronto, presented the results at the meeting.
About 10% of the enrolled patients met ARDS criteria; of those, less than two-thirds received ventilator tidal volumes of 8 mL/kg or less of predicted body weight. Fewer than 18% of patients received positive end–expiratory pressure (PEEP) of more than 12 cm H2O, and clinicians used prone positioning for about 16% of patients with severe ARDS.
Clinicians recognized 60.2% of ARDS cases overall; recognition ranged from 51.3% of the cases of mild ARDS to 78.5% of the severe ARDS cases. For all patients, ARDS was associated with an in-hospital mortality rate of 40%. Nearly half of those with severe ARDS died, as did over a third of those with mild ARDS.
To this end, the LUNG SAFE investigators chose 4 consecutive weeks in the winter to enroll patients from a convenience sample of ICUs that they attempted to make broadly representative. They enrolled during February and March 2014 in the Northern hemisphere and July and August 2014 in the Southern hemisphere, and included all patients 16 years and older who were admitted to a participating ICU and received invasive or noninvasive ventilation.
Enrolled patients received daily evaluation for acute hypoxemic respiratory failure. Patients who met these criteria were then tracked with expanded data collection up to day 28 after respiratory failure was identified, or until ICU discharge or death. Overall, 3,022 patients met the Berlin Definition for ARDS. All but 436 patients (85.4%) received invasive ventilation, and those who did not were excluded from most data analysis.
One unexpected finding, said Dr. Laffey in an interview, was how common ARDS was in this ICU population. “Based on prior studies, we had anticipated finding an incidence of ARDS of approximately half of what we actually found in the LUNG SAFE study. We think that the difference is explained by the fact that we did not rely on clinician recognition of ARDS, but rather collected data directly on each of the Berlin diagnostic criteria, enabling us to make the diagnosis directly.” One possibility is that choosing the winter months for data collection may have resulted in overrepresentation of ARDS.
But Dr. Laffey said that LUNG SAFE’s most surprising finding was the low percentage of clinicians using higher PEEP levels. “It appeared that clinicians used lower-than-expected levels of PEEP, and that the use of PEEP didn’t increase in patients with the more severe forms of ARDS,” he said. “We think we need to increase our efforts to find more reliable ways to diagnose ARDS,” said Dr. Laffey. “While the reasons underlying clinician failure to recognize ARDS in critically ill patients are complex, the fact that there is no single test for diagnosing ARDS is a likely contributing factor.”
“This finding likely reflects the lack of a clear evidence base for the effectiveness of higher levels of PEEP in patients with ARDS” said Dr. Laffey. “It emphasizes the need for additional research to answer this and other important questions relating to the optimal treatment of patients with ARDS.”
However, if physicians did recognize ARDS, then they were more likely to use higher PEEPs (mean 8.9 cm H2O vs. 7.5 cm H2O for nonrecognized ARDS; P less than .001), prone positioning, and neuromuscular blockade (43.9% adjunctive treatment vs. 21.7% adjunctive treatment for nonrecognized ARDS; P less than .001), though they didn’t adjust the breath size used in ventilation.
In multivariable analysis, factors that made it more likely that ARDS would be recognized were higher nurse-to-patient and physician-to-patient ratios, younger patient age, lower Pa02/Fi02 ratios, and a pneumonia or pancreatitis diagnosis. Patients without an identified risk factor, and those with heart failure, were less likely to be diagnosed with ARDS.
The study was supported by the European Society of Intensive Care Medicine, by St. Michael’s Hospital, Toronto, and by the University of Milan-Bicocca, Monza, Italy. The authors reported no conflicts of interest.
On Twitter @karioakes
ORLANDO – Many patients meeting the criteria for acute respiratory distress syndrome (ARDS) went unrecognized in a global sample of ICU patients, and those ARDS patients did not receive adjusted ventilator management or positioning and pharmacologic adjunctive treatments, based on the results of the LUNG SAFE study.
Enrolling nearly 30,000 patients in 50 countries on five continents, the LUNG SAFE study (Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure) looked for real-world answers to whether and how patients with ARDS are treated. The LUNG SAFE results were published concurrently with the presentation of results in a late-breaking session at the Critical Care Congress, sponsored by the Society of Critical Care Medicine (JAMA. 2016;315[8]:759-61). The first author is Dr. Giacomo Bellani, professor of medicine at the University of Milan-Bicocca, Monza, Italy, and Dr. John Laffey, professor of anesthesia, critical care, and physiology at the University of Toronto, presented the results at the meeting.
About 10% of the enrolled patients met ARDS criteria; of those, less than two-thirds received ventilator tidal volumes of 8 mL/kg or less of predicted body weight. Fewer than 18% of patients received positive end–expiratory pressure (PEEP) of more than 12 cm H2O, and clinicians used prone positioning for about 16% of patients with severe ARDS.
Clinicians recognized 60.2% of ARDS cases overall; recognition ranged from 51.3% of the cases of mild ARDS to 78.5% of the severe ARDS cases. For all patients, ARDS was associated with an in-hospital mortality rate of 40%. Nearly half of those with severe ARDS died, as did over a third of those with mild ARDS.
To this end, the LUNG SAFE investigators chose 4 consecutive weeks in the winter to enroll patients from a convenience sample of ICUs that they attempted to make broadly representative. They enrolled during February and March 2014 in the Northern hemisphere and July and August 2014 in the Southern hemisphere, and included all patients 16 years and older who were admitted to a participating ICU and received invasive or noninvasive ventilation.
Enrolled patients received daily evaluation for acute hypoxemic respiratory failure. Patients who met these criteria were then tracked with expanded data collection up to day 28 after respiratory failure was identified, or until ICU discharge or death. Overall, 3,022 patients met the Berlin Definition for ARDS. All but 436 patients (85.4%) received invasive ventilation, and those who did not were excluded from most data analysis.
One unexpected finding, said Dr. Laffey in an interview, was how common ARDS was in this ICU population. “Based on prior studies, we had anticipated finding an incidence of ARDS of approximately half of what we actually found in the LUNG SAFE study. We think that the difference is explained by the fact that we did not rely on clinician recognition of ARDS, but rather collected data directly on each of the Berlin diagnostic criteria, enabling us to make the diagnosis directly.” One possibility is that choosing the winter months for data collection may have resulted in overrepresentation of ARDS.
But Dr. Laffey said that LUNG SAFE’s most surprising finding was the low percentage of clinicians using higher PEEP levels. “It appeared that clinicians used lower-than-expected levels of PEEP, and that the use of PEEP didn’t increase in patients with the more severe forms of ARDS,” he said. “We think we need to increase our efforts to find more reliable ways to diagnose ARDS,” said Dr. Laffey. “While the reasons underlying clinician failure to recognize ARDS in critically ill patients are complex, the fact that there is no single test for diagnosing ARDS is a likely contributing factor.”
“This finding likely reflects the lack of a clear evidence base for the effectiveness of higher levels of PEEP in patients with ARDS” said Dr. Laffey. “It emphasizes the need for additional research to answer this and other important questions relating to the optimal treatment of patients with ARDS.”
However, if physicians did recognize ARDS, then they were more likely to use higher PEEPs (mean 8.9 cm H2O vs. 7.5 cm H2O for nonrecognized ARDS; P less than .001), prone positioning, and neuromuscular blockade (43.9% adjunctive treatment vs. 21.7% adjunctive treatment for nonrecognized ARDS; P less than .001), though they didn’t adjust the breath size used in ventilation.
In multivariable analysis, factors that made it more likely that ARDS would be recognized were higher nurse-to-patient and physician-to-patient ratios, younger patient age, lower Pa02/Fi02 ratios, and a pneumonia or pancreatitis diagnosis. Patients without an identified risk factor, and those with heart failure, were less likely to be diagnosed with ARDS.
The study was supported by the European Society of Intensive Care Medicine, by St. Michael’s Hospital, Toronto, and by the University of Milan-Bicocca, Monza, Italy. The authors reported no conflicts of interest.
On Twitter @karioakes
ORLANDO – Many patients meeting the criteria for acute respiratory distress syndrome (ARDS) went unrecognized in a global sample of ICU patients, and those ARDS patients did not receive adjusted ventilator management or positioning and pharmacologic adjunctive treatments, based on the results of the LUNG SAFE study.
Enrolling nearly 30,000 patients in 50 countries on five continents, the LUNG SAFE study (Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure) looked for real-world answers to whether and how patients with ARDS are treated. The LUNG SAFE results were published concurrently with the presentation of results in a late-breaking session at the Critical Care Congress, sponsored by the Society of Critical Care Medicine (JAMA. 2016;315[8]:759-61). The first author is Dr. Giacomo Bellani, professor of medicine at the University of Milan-Bicocca, Monza, Italy, and Dr. John Laffey, professor of anesthesia, critical care, and physiology at the University of Toronto, presented the results at the meeting.
About 10% of the enrolled patients met ARDS criteria; of those, less than two-thirds received ventilator tidal volumes of 8 mL/kg or less of predicted body weight. Fewer than 18% of patients received positive end–expiratory pressure (PEEP) of more than 12 cm H2O, and clinicians used prone positioning for about 16% of patients with severe ARDS.
Clinicians recognized 60.2% of ARDS cases overall; recognition ranged from 51.3% of the cases of mild ARDS to 78.5% of the severe ARDS cases. For all patients, ARDS was associated with an in-hospital mortality rate of 40%. Nearly half of those with severe ARDS died, as did over a third of those with mild ARDS.
To this end, the LUNG SAFE investigators chose 4 consecutive weeks in the winter to enroll patients from a convenience sample of ICUs that they attempted to make broadly representative. They enrolled during February and March 2014 in the Northern hemisphere and July and August 2014 in the Southern hemisphere, and included all patients 16 years and older who were admitted to a participating ICU and received invasive or noninvasive ventilation.
Enrolled patients received daily evaluation for acute hypoxemic respiratory failure. Patients who met these criteria were then tracked with expanded data collection up to day 28 after respiratory failure was identified, or until ICU discharge or death. Overall, 3,022 patients met the Berlin Definition for ARDS. All but 436 patients (85.4%) received invasive ventilation, and those who did not were excluded from most data analysis.
One unexpected finding, said Dr. Laffey in an interview, was how common ARDS was in this ICU population. “Based on prior studies, we had anticipated finding an incidence of ARDS of approximately half of what we actually found in the LUNG SAFE study. We think that the difference is explained by the fact that we did not rely on clinician recognition of ARDS, but rather collected data directly on each of the Berlin diagnostic criteria, enabling us to make the diagnosis directly.” One possibility is that choosing the winter months for data collection may have resulted in overrepresentation of ARDS.
But Dr. Laffey said that LUNG SAFE’s most surprising finding was the low percentage of clinicians using higher PEEP levels. “It appeared that clinicians used lower-than-expected levels of PEEP, and that the use of PEEP didn’t increase in patients with the more severe forms of ARDS,” he said. “We think we need to increase our efforts to find more reliable ways to diagnose ARDS,” said Dr. Laffey. “While the reasons underlying clinician failure to recognize ARDS in critically ill patients are complex, the fact that there is no single test for diagnosing ARDS is a likely contributing factor.”
“This finding likely reflects the lack of a clear evidence base for the effectiveness of higher levels of PEEP in patients with ARDS” said Dr. Laffey. “It emphasizes the need for additional research to answer this and other important questions relating to the optimal treatment of patients with ARDS.”
However, if physicians did recognize ARDS, then they were more likely to use higher PEEPs (mean 8.9 cm H2O vs. 7.5 cm H2O for nonrecognized ARDS; P less than .001), prone positioning, and neuromuscular blockade (43.9% adjunctive treatment vs. 21.7% adjunctive treatment for nonrecognized ARDS; P less than .001), though they didn’t adjust the breath size used in ventilation.
In multivariable analysis, factors that made it more likely that ARDS would be recognized were higher nurse-to-patient and physician-to-patient ratios, younger patient age, lower Pa02/Fi02 ratios, and a pneumonia or pancreatitis diagnosis. Patients without an identified risk factor, and those with heart failure, were less likely to be diagnosed with ARDS.
The study was supported by the European Society of Intensive Care Medicine, by St. Michael’s Hospital, Toronto, and by the University of Milan-Bicocca, Monza, Italy. The authors reported no conflicts of interest.
On Twitter @karioakes
AT THE CRITICAL CARE CONGRESS
Key clinical point: Acute respiratory distress syndrome (ARDS) was under-recognized and did not receive adjusted management in a global sample of ICU patients.
Major finding: 10.4% of ICU patients fulfilled ARDS criteria; clinician recognition ranged from 51% to 78% of cases.
Data source: Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure (LUNG SAFE), an international multicenter prospective cohort study of 29,144 patients receiving invasive or noninvasive ventilation in 459 ICUs from 50 countries, over a period of 4 weeks in 2014.
Disclosures: The study was supported by the European Society of Intensive Care Medicine, by St. Michael’s Hospital, Toronto, and by the University of Milan-Bicocca, Monza, Italy. The authors reported no conflicts of interest.
Sepsis redefined by joint U.S.-European critical care task force
ORLANDO – New consensus definitions for sepsis and septic shock focus on host dysregulation in the face of infection, propose a three-item quick-scoring option for bedside assessment, and introduce serum lactate as an important marker of cellular metabolic stress in identifying septic shock.
Sepsis is now defined as “life-threatening organ dysfunction caused by a dysregulated host response to infection,” according to a 19-member task force convened jointly by the U.S. Society for Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM) (JAMA. 2016;315[8]:801-10. doi: 10.1001/jama.2016.0287).
Since sepsis itself is inherently a life-threatening diagnosis, the term “severe sepsis” is redundant and should be eliminated, according to Dr. Mervyn Singer and his fellow task force members and coauthors. Together with his coauthors, Dr. Singer, professor of intensive care medicine at University College London, also recommended moving away from an “excessive focus on inflammation” and “the misleading model that sepsis follows a continuum through severe sepsis to shock.”
Systemic inflammatory response syndrome (SIRS) is a serious manifestation of an appropriate host response to infection, rather than the dysregulated host response that characterizes sepsis. So although it’s no longer included in sepsis criteria. “We are not discounting SIRS,” Dr. Singer said in a presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. The consensus statement was released and the presentation was made simultaneously.
Organ dysfunction, for the purposes of the revised definition, is defined as a 2 or more point increase in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score. This increase is associated with a 10% or more rise in mortality while in hospital. Task force members, after review, recommended standardizing sepsis assessment with the SOFA score.
The criteria require an increase of 2 or more points on the SOFA score because many patients suspected of sepsis will have comorbidities that will “earn” them SOFA points at baseline, said Dr. Singer.
Operationalizing the sepsis definition through SOFA made sense, said Dr. Singer, because the set of five laboratory measures and one clinician-administered scale – the Glasgow Coma Scale (GCS) – are already likely to be part of daily assessments for a seriously ill hospitalized adult.
Septic shock, as defined by the task force, is associated with in-hospital mortality of over 40%. Septic shock is now defined as “a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone.” Clinically, patients have septic shock if they require a vasopressor to maintain a mean arterial pressure of 65 mm Hg or greater, and have a serum lactate level greater than 18 mg/dL (2 mmol/L) without hypovolemia.
The definitions introduce an abbreviated bedside sepsis identification tool termed quickSOFA (qSOFA). For adults suspected of infection, qSOFA requires two of the three clinical criteria of respiratory rate of 22 breaths/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less. “This model was robust to multiple sensitivity analyses,” wrote Dr. Singer and his coauthors, and worked well in out-of-hospital, emergency department, and ward settings both within and outside of the United States. “We are encouraging prospective validation in different health care settings,” for example, in resource-poor environments, said Dr. Singer.
The extensive review process included a large meta-analysis and systematic review of observational studies of adults with sepsis to evaluate diagnostic systems and criteria currently in use. The results of the review were used to inform the task force’s Delphi study, which then led to cohort studies to test the proposed variables, through the Surviving Sepsis Campaign. A comprehensive description of the work of the task force was published concurrently with the new sepsis and septic shock definitions (JAMA. 2016;315[8]:775-87. doi: 10.1001/jama.2016.0289).
“We had what I call a soft launch” of the new definitions, said Dr. Singer. The definitions and criteria have been available for review and discussion for about a year, and discussions in the public forum are already shaping thoughts about the way forward. “We expect lots and lots of discussion,” said Dr. Singer.
Limitations of the new definitions were enumerated by Dr. Singer and his coauthors, and also brought forward in an accompanying editorial by Dr. Edward Abraham, dean of the Wake Forest School of Medicine, Winston-Salem, N.C. These include that sepsis is not defined for children, that the reliance on serum lactate levels may not be feasible in resource-poor environments, and that there are limitations to the datasets used to generate the new guidelines.
The guidelines also offer suggested International Classification of Diseases-9 (ICD-9) and ICD-10 codes for sepsis and septic shock, in the hope that “greater clarity and consistency will also facilitate research and more accurate coding,” wrote Dr. Singer and his coauthors.
Multiple task force members reported relationships with pharmaceutical companies. The work of the task force was supported in part by grants from SCCM and ESICM.
The guidelines and accompanying information are available at www.sccm.org/sepsisredefined.
On Twitter @karioakes
ORLANDO – New consensus definitions for sepsis and septic shock focus on host dysregulation in the face of infection, propose a three-item quick-scoring option for bedside assessment, and introduce serum lactate as an important marker of cellular metabolic stress in identifying septic shock.
Sepsis is now defined as “life-threatening organ dysfunction caused by a dysregulated host response to infection,” according to a 19-member task force convened jointly by the U.S. Society for Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM) (JAMA. 2016;315[8]:801-10. doi: 10.1001/jama.2016.0287).
Since sepsis itself is inherently a life-threatening diagnosis, the term “severe sepsis” is redundant and should be eliminated, according to Dr. Mervyn Singer and his fellow task force members and coauthors. Together with his coauthors, Dr. Singer, professor of intensive care medicine at University College London, also recommended moving away from an “excessive focus on inflammation” and “the misleading model that sepsis follows a continuum through severe sepsis to shock.”
Systemic inflammatory response syndrome (SIRS) is a serious manifestation of an appropriate host response to infection, rather than the dysregulated host response that characterizes sepsis. So although it’s no longer included in sepsis criteria. “We are not discounting SIRS,” Dr. Singer said in a presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. The consensus statement was released and the presentation was made simultaneously.
Organ dysfunction, for the purposes of the revised definition, is defined as a 2 or more point increase in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score. This increase is associated with a 10% or more rise in mortality while in hospital. Task force members, after review, recommended standardizing sepsis assessment with the SOFA score.
The criteria require an increase of 2 or more points on the SOFA score because many patients suspected of sepsis will have comorbidities that will “earn” them SOFA points at baseline, said Dr. Singer.
Operationalizing the sepsis definition through SOFA made sense, said Dr. Singer, because the set of five laboratory measures and one clinician-administered scale – the Glasgow Coma Scale (GCS) – are already likely to be part of daily assessments for a seriously ill hospitalized adult.
Septic shock, as defined by the task force, is associated with in-hospital mortality of over 40%. Septic shock is now defined as “a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone.” Clinically, patients have septic shock if they require a vasopressor to maintain a mean arterial pressure of 65 mm Hg or greater, and have a serum lactate level greater than 18 mg/dL (2 mmol/L) without hypovolemia.
The definitions introduce an abbreviated bedside sepsis identification tool termed quickSOFA (qSOFA). For adults suspected of infection, qSOFA requires two of the three clinical criteria of respiratory rate of 22 breaths/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less. “This model was robust to multiple sensitivity analyses,” wrote Dr. Singer and his coauthors, and worked well in out-of-hospital, emergency department, and ward settings both within and outside of the United States. “We are encouraging prospective validation in different health care settings,” for example, in resource-poor environments, said Dr. Singer.
The extensive review process included a large meta-analysis and systematic review of observational studies of adults with sepsis to evaluate diagnostic systems and criteria currently in use. The results of the review were used to inform the task force’s Delphi study, which then led to cohort studies to test the proposed variables, through the Surviving Sepsis Campaign. A comprehensive description of the work of the task force was published concurrently with the new sepsis and septic shock definitions (JAMA. 2016;315[8]:775-87. doi: 10.1001/jama.2016.0289).
“We had what I call a soft launch” of the new definitions, said Dr. Singer. The definitions and criteria have been available for review and discussion for about a year, and discussions in the public forum are already shaping thoughts about the way forward. “We expect lots and lots of discussion,” said Dr. Singer.
Limitations of the new definitions were enumerated by Dr. Singer and his coauthors, and also brought forward in an accompanying editorial by Dr. Edward Abraham, dean of the Wake Forest School of Medicine, Winston-Salem, N.C. These include that sepsis is not defined for children, that the reliance on serum lactate levels may not be feasible in resource-poor environments, and that there are limitations to the datasets used to generate the new guidelines.
The guidelines also offer suggested International Classification of Diseases-9 (ICD-9) and ICD-10 codes for sepsis and septic shock, in the hope that “greater clarity and consistency will also facilitate research and more accurate coding,” wrote Dr. Singer and his coauthors.
Multiple task force members reported relationships with pharmaceutical companies. The work of the task force was supported in part by grants from SCCM and ESICM.
The guidelines and accompanying information are available at www.sccm.org/sepsisredefined.
On Twitter @karioakes
ORLANDO – New consensus definitions for sepsis and septic shock focus on host dysregulation in the face of infection, propose a three-item quick-scoring option for bedside assessment, and introduce serum lactate as an important marker of cellular metabolic stress in identifying septic shock.
Sepsis is now defined as “life-threatening organ dysfunction caused by a dysregulated host response to infection,” according to a 19-member task force convened jointly by the U.S. Society for Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM) (JAMA. 2016;315[8]:801-10. doi: 10.1001/jama.2016.0287).
Since sepsis itself is inherently a life-threatening diagnosis, the term “severe sepsis” is redundant and should be eliminated, according to Dr. Mervyn Singer and his fellow task force members and coauthors. Together with his coauthors, Dr. Singer, professor of intensive care medicine at University College London, also recommended moving away from an “excessive focus on inflammation” and “the misleading model that sepsis follows a continuum through severe sepsis to shock.”
Systemic inflammatory response syndrome (SIRS) is a serious manifestation of an appropriate host response to infection, rather than the dysregulated host response that characterizes sepsis. So although it’s no longer included in sepsis criteria. “We are not discounting SIRS,” Dr. Singer said in a presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. The consensus statement was released and the presentation was made simultaneously.
Organ dysfunction, for the purposes of the revised definition, is defined as a 2 or more point increase in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score. This increase is associated with a 10% or more rise in mortality while in hospital. Task force members, after review, recommended standardizing sepsis assessment with the SOFA score.
The criteria require an increase of 2 or more points on the SOFA score because many patients suspected of sepsis will have comorbidities that will “earn” them SOFA points at baseline, said Dr. Singer.
Operationalizing the sepsis definition through SOFA made sense, said Dr. Singer, because the set of five laboratory measures and one clinician-administered scale – the Glasgow Coma Scale (GCS) – are already likely to be part of daily assessments for a seriously ill hospitalized adult.
Septic shock, as defined by the task force, is associated with in-hospital mortality of over 40%. Septic shock is now defined as “a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone.” Clinically, patients have septic shock if they require a vasopressor to maintain a mean arterial pressure of 65 mm Hg or greater, and have a serum lactate level greater than 18 mg/dL (2 mmol/L) without hypovolemia.
The definitions introduce an abbreviated bedside sepsis identification tool termed quickSOFA (qSOFA). For adults suspected of infection, qSOFA requires two of the three clinical criteria of respiratory rate of 22 breaths/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less. “This model was robust to multiple sensitivity analyses,” wrote Dr. Singer and his coauthors, and worked well in out-of-hospital, emergency department, and ward settings both within and outside of the United States. “We are encouraging prospective validation in different health care settings,” for example, in resource-poor environments, said Dr. Singer.
The extensive review process included a large meta-analysis and systematic review of observational studies of adults with sepsis to evaluate diagnostic systems and criteria currently in use. The results of the review were used to inform the task force’s Delphi study, which then led to cohort studies to test the proposed variables, through the Surviving Sepsis Campaign. A comprehensive description of the work of the task force was published concurrently with the new sepsis and septic shock definitions (JAMA. 2016;315[8]:775-87. doi: 10.1001/jama.2016.0289).
“We had what I call a soft launch” of the new definitions, said Dr. Singer. The definitions and criteria have been available for review and discussion for about a year, and discussions in the public forum are already shaping thoughts about the way forward. “We expect lots and lots of discussion,” said Dr. Singer.
Limitations of the new definitions were enumerated by Dr. Singer and his coauthors, and also brought forward in an accompanying editorial by Dr. Edward Abraham, dean of the Wake Forest School of Medicine, Winston-Salem, N.C. These include that sepsis is not defined for children, that the reliance on serum lactate levels may not be feasible in resource-poor environments, and that there are limitations to the datasets used to generate the new guidelines.
The guidelines also offer suggested International Classification of Diseases-9 (ICD-9) and ICD-10 codes for sepsis and septic shock, in the hope that “greater clarity and consistency will also facilitate research and more accurate coding,” wrote Dr. Singer and his coauthors.
Multiple task force members reported relationships with pharmaceutical companies. The work of the task force was supported in part by grants from SCCM and ESICM.
The guidelines and accompanying information are available at www.sccm.org/sepsisredefined.
On Twitter @karioakes
AT THE CRITICAL CARE CONGRESS