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Dr. Paul E. Marik proclaims end to corticosteroid monotherapy for sepsis
SAN ANTONIO – While critical care specialists await more data on a so-called sepsis cocktail with varying degrees of hope and skepticism, Paul E. Marik, MD, FCCP, has proclaimed the dawning of a new era.
Dr. Marik became a celebrity in the critical care medicine community after he and his colleagues reported the results of his retrospective study evaluating the combination of hydrocortisone, vitamin C, and thiamine for treatment of severe sepsis and septic shock (Chest. 2017 June. doi: 10.1016/j.chest.2016.11.036).
Since this study, several physicians have already been putting Dr. Marik’s method to practice, the investigator and audience members noted during a session at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
in his presentation at the meeting.
These comments echoed Dr. Marik’s May 2017 editorial in Critical Care Medicine, in which he suggested that critically ill and injured patients may benefit from combination therapy with hydrocortisone and vitamin C (Crit Care Med 2017 May;45[5]910-1).
That editorial was quickly followed by the report on Dr. Marik and colleagues’ before-after study, in which hospital mortality was 8.5%, versus 0.4% in the treatment and control groups, respectively (P less than .001). This finding led the investigators to suggest that intravenous vitamin C administered along with corticosteroids and thiamine is “effective” in reducing mortality, in their paper published in CHEST®.
During Dr. Marik’s presentation at the meeting, he noted that he had been “misquoted” with regard to the finality of his study’s results. The final line of the CHEST® paper reads, “Additional studies are required to confirm these preliminary findings,” he emphasized.
Nevertheless, Dr. Marik alluded to a “big paradigm shift” in the treatment of sepsis.
“Our experience has been echoed by now hundreds, if not thousands, of clinicians across the world,” said Dr. Marik, chief of the division of pulmonary and critical care medicine, Eastern Virginia Medical School, Norfolk.
He recounted an anecdotal case submitted by “Josh from Ohio” describing an elderly man who was “started on cocktail and within a day his pressor requirements melted away and he was extubated.” Quoting “Josh from Ohio,” Dr. Mark continued, “Tomorrow he will probably leave the ICU with no residual organ dysfunction, no volume overload, (and) no ICU complications.”
Eddy Gutierrez, MD, of Jacksonville, Fla., noted in a question-and-answer period that he has had “positive results” with a similar approach.
“When we first learned about the vitamin C and the ‘Marik protocol,’ so to speak, I was in fellowship and I got laughed at,” Dr. Gutierrez said. “Nobody would let me try it.”
Others are taking a wait-and-see approach.
Greg S. Martin, MD, secretary of the Society of Critical Care Medicine, said in an interview that there are “at least two schools of thought” among critical care specialists regarding the use of hydrocortisone, vitamin C, and thiamine for treatment of sepsis and septic shock.
“One school of thought is that this is incredibly important if this is even fractionally as effective as what [Dr. Marik] showed, because we have not found an effective therapy for sepsis,” said Dr. Martin, associate professor of medicine at Grady Memorial Hospital, Atlanta.
“The contrarian approach is to say, ‘yes, but this seems remarkably unlikely to be as effective as what he has shown,’ ” Dr. Martin added. “Particularly in sepsis, people are very skeptical of whether a drug or a drug combination is going to be as effective when you really get down to a high-quality randomized controlled trial that would be the definitive level of evidence.”
The wait may not be long for at least some data. Multiple clinical trials are recruiting or planned, according to Dr. Marik. These included a 140-patient U.S. randomized, double-blind trial of vitamin C, hydrocortisone, and thiamine vs. placebo that started in February 2018 and is expected to be completed by February 2019, according to the study’s ClinicalTrials.gov listing.
“The good news is some people think this is of value,” Dr. Marik said.
As part of his presentation, Dr. Marik reported a disclosure related to Baxter (advisory board).
SAN ANTONIO – While critical care specialists await more data on a so-called sepsis cocktail with varying degrees of hope and skepticism, Paul E. Marik, MD, FCCP, has proclaimed the dawning of a new era.
Dr. Marik became a celebrity in the critical care medicine community after he and his colleagues reported the results of his retrospective study evaluating the combination of hydrocortisone, vitamin C, and thiamine for treatment of severe sepsis and septic shock (Chest. 2017 June. doi: 10.1016/j.chest.2016.11.036).
Since this study, several physicians have already been putting Dr. Marik’s method to practice, the investigator and audience members noted during a session at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
in his presentation at the meeting.
These comments echoed Dr. Marik’s May 2017 editorial in Critical Care Medicine, in which he suggested that critically ill and injured patients may benefit from combination therapy with hydrocortisone and vitamin C (Crit Care Med 2017 May;45[5]910-1).
That editorial was quickly followed by the report on Dr. Marik and colleagues’ before-after study, in which hospital mortality was 8.5%, versus 0.4% in the treatment and control groups, respectively (P less than .001). This finding led the investigators to suggest that intravenous vitamin C administered along with corticosteroids and thiamine is “effective” in reducing mortality, in their paper published in CHEST®.
During Dr. Marik’s presentation at the meeting, he noted that he had been “misquoted” with regard to the finality of his study’s results. The final line of the CHEST® paper reads, “Additional studies are required to confirm these preliminary findings,” he emphasized.
Nevertheless, Dr. Marik alluded to a “big paradigm shift” in the treatment of sepsis.
“Our experience has been echoed by now hundreds, if not thousands, of clinicians across the world,” said Dr. Marik, chief of the division of pulmonary and critical care medicine, Eastern Virginia Medical School, Norfolk.
He recounted an anecdotal case submitted by “Josh from Ohio” describing an elderly man who was “started on cocktail and within a day his pressor requirements melted away and he was extubated.” Quoting “Josh from Ohio,” Dr. Mark continued, “Tomorrow he will probably leave the ICU with no residual organ dysfunction, no volume overload, (and) no ICU complications.”
Eddy Gutierrez, MD, of Jacksonville, Fla., noted in a question-and-answer period that he has had “positive results” with a similar approach.
“When we first learned about the vitamin C and the ‘Marik protocol,’ so to speak, I was in fellowship and I got laughed at,” Dr. Gutierrez said. “Nobody would let me try it.”
Others are taking a wait-and-see approach.
Greg S. Martin, MD, secretary of the Society of Critical Care Medicine, said in an interview that there are “at least two schools of thought” among critical care specialists regarding the use of hydrocortisone, vitamin C, and thiamine for treatment of sepsis and septic shock.
“One school of thought is that this is incredibly important if this is even fractionally as effective as what [Dr. Marik] showed, because we have not found an effective therapy for sepsis,” said Dr. Martin, associate professor of medicine at Grady Memorial Hospital, Atlanta.
“The contrarian approach is to say, ‘yes, but this seems remarkably unlikely to be as effective as what he has shown,’ ” Dr. Martin added. “Particularly in sepsis, people are very skeptical of whether a drug or a drug combination is going to be as effective when you really get down to a high-quality randomized controlled trial that would be the definitive level of evidence.”
The wait may not be long for at least some data. Multiple clinical trials are recruiting or planned, according to Dr. Marik. These included a 140-patient U.S. randomized, double-blind trial of vitamin C, hydrocortisone, and thiamine vs. placebo that started in February 2018 and is expected to be completed by February 2019, according to the study’s ClinicalTrials.gov listing.
“The good news is some people think this is of value,” Dr. Marik said.
As part of his presentation, Dr. Marik reported a disclosure related to Baxter (advisory board).
SAN ANTONIO – While critical care specialists await more data on a so-called sepsis cocktail with varying degrees of hope and skepticism, Paul E. Marik, MD, FCCP, has proclaimed the dawning of a new era.
Dr. Marik became a celebrity in the critical care medicine community after he and his colleagues reported the results of his retrospective study evaluating the combination of hydrocortisone, vitamin C, and thiamine for treatment of severe sepsis and septic shock (Chest. 2017 June. doi: 10.1016/j.chest.2016.11.036).
Since this study, several physicians have already been putting Dr. Marik’s method to practice, the investigator and audience members noted during a session at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
in his presentation at the meeting.
These comments echoed Dr. Marik’s May 2017 editorial in Critical Care Medicine, in which he suggested that critically ill and injured patients may benefit from combination therapy with hydrocortisone and vitamin C (Crit Care Med 2017 May;45[5]910-1).
That editorial was quickly followed by the report on Dr. Marik and colleagues’ before-after study, in which hospital mortality was 8.5%, versus 0.4% in the treatment and control groups, respectively (P less than .001). This finding led the investigators to suggest that intravenous vitamin C administered along with corticosteroids and thiamine is “effective” in reducing mortality, in their paper published in CHEST®.
During Dr. Marik’s presentation at the meeting, he noted that he had been “misquoted” with regard to the finality of his study’s results. The final line of the CHEST® paper reads, “Additional studies are required to confirm these preliminary findings,” he emphasized.
Nevertheless, Dr. Marik alluded to a “big paradigm shift” in the treatment of sepsis.
“Our experience has been echoed by now hundreds, if not thousands, of clinicians across the world,” said Dr. Marik, chief of the division of pulmonary and critical care medicine, Eastern Virginia Medical School, Norfolk.
He recounted an anecdotal case submitted by “Josh from Ohio” describing an elderly man who was “started on cocktail and within a day his pressor requirements melted away and he was extubated.” Quoting “Josh from Ohio,” Dr. Mark continued, “Tomorrow he will probably leave the ICU with no residual organ dysfunction, no volume overload, (and) no ICU complications.”
Eddy Gutierrez, MD, of Jacksonville, Fla., noted in a question-and-answer period that he has had “positive results” with a similar approach.
“When we first learned about the vitamin C and the ‘Marik protocol,’ so to speak, I was in fellowship and I got laughed at,” Dr. Gutierrez said. “Nobody would let me try it.”
Others are taking a wait-and-see approach.
Greg S. Martin, MD, secretary of the Society of Critical Care Medicine, said in an interview that there are “at least two schools of thought” among critical care specialists regarding the use of hydrocortisone, vitamin C, and thiamine for treatment of sepsis and septic shock.
“One school of thought is that this is incredibly important if this is even fractionally as effective as what [Dr. Marik] showed, because we have not found an effective therapy for sepsis,” said Dr. Martin, associate professor of medicine at Grady Memorial Hospital, Atlanta.
“The contrarian approach is to say, ‘yes, but this seems remarkably unlikely to be as effective as what he has shown,’ ” Dr. Martin added. “Particularly in sepsis, people are very skeptical of whether a drug or a drug combination is going to be as effective when you really get down to a high-quality randomized controlled trial that would be the definitive level of evidence.”
The wait may not be long for at least some data. Multiple clinical trials are recruiting or planned, according to Dr. Marik. These included a 140-patient U.S. randomized, double-blind trial of vitamin C, hydrocortisone, and thiamine vs. placebo that started in February 2018 and is expected to be completed by February 2019, according to the study’s ClinicalTrials.gov listing.
“The good news is some people think this is of value,” Dr. Marik said.
As part of his presentation, Dr. Marik reported a disclosure related to Baxter (advisory board).
REPORTING FROM CCC47
Critical illness-related corticosteroid insufficiency guidelines explained
SAN ANTONIO – When corticosteroids are used for septic shock, the dose should be low to moderate, the timing should be early, and the duration should be at least 3 days, said a speaker at the Critical Care Congress sponsored by the Society for Critical Care.
Dosing, timing, and duration are “three critical questions” critical care specialists face that are answered by the new critical illness–related corticosteroid insufficiency (CIRCI) guidelines, continued Stephen M. Pastores, MD, a cochair of the task force that developed guidelines for the diagnosis and management of CIRCI in critically ill patients.
During his presentation, Dr. Pastores limited his remarks to discussion of sepsis and septic shock with corticosteroids. He cautioned that, despite careful deliberations by the panel, the level of evidence behind some of the recommendations was “low to moderate and never high” and that not all task force members agreed with all recommendations.
“There were a lot of back and forth disagreements behind these recommendations,” said Dr. Pastores, who is the director of the critical care medicine fellowship training and research programs at Memorial Sloan Kettering Cancer Center, New York. “We only required 80% of the panelists to agree that these were the recommendations and statements that we were going to go by.”
The guidelines recommend against the use of corticosteroids in adult patients who have sepsis without shock, Dr. Pastores noted.
In contrast,
In an analysis of available data from randomized clinical trials including patients with septic shock, corticosteroids significantly reduced 28-day mortality when compared with placebo, Dr. Pastores said.
That survival benefit seems to be dependent on several factors: dose of the corticosteroids (hydrocortisone less than 400 mg/day), longer duration (at least 3 or more days), and severity of sepsis. “The more severe the sepsis, the more septic shock the patient was in, the more likely the corticosteroids were likely to help those patients,” Dr. Pastores explained.
Accordingly, the guidelines further suggest using long-course, low-dose corticosteroid treatment, namely intravenous hydrocortisone at no more than 400 mg/day for at least 3 days.
The expert panel specifically recommended hydrocortisone as the corticosteroid of choice in this setting, according to Dr. Pastores. That recommendation was based in part on a recent systematic review and meta-analysis showing that hydrocortisone, given as a bolus or an infusion, was more likely than placebo or methylprednisolone to result in shock reversal.
Dr. Pastores reported disclosures related to Theravance Biopharma, Bayer HealthCare Pharmaceuticals, Spectral Diagnostics, and Asahi-Kasei.
SAN ANTONIO – When corticosteroids are used for septic shock, the dose should be low to moderate, the timing should be early, and the duration should be at least 3 days, said a speaker at the Critical Care Congress sponsored by the Society for Critical Care.
Dosing, timing, and duration are “three critical questions” critical care specialists face that are answered by the new critical illness–related corticosteroid insufficiency (CIRCI) guidelines, continued Stephen M. Pastores, MD, a cochair of the task force that developed guidelines for the diagnosis and management of CIRCI in critically ill patients.
During his presentation, Dr. Pastores limited his remarks to discussion of sepsis and septic shock with corticosteroids. He cautioned that, despite careful deliberations by the panel, the level of evidence behind some of the recommendations was “low to moderate and never high” and that not all task force members agreed with all recommendations.
“There were a lot of back and forth disagreements behind these recommendations,” said Dr. Pastores, who is the director of the critical care medicine fellowship training and research programs at Memorial Sloan Kettering Cancer Center, New York. “We only required 80% of the panelists to agree that these were the recommendations and statements that we were going to go by.”
The guidelines recommend against the use of corticosteroids in adult patients who have sepsis without shock, Dr. Pastores noted.
In contrast,
In an analysis of available data from randomized clinical trials including patients with septic shock, corticosteroids significantly reduced 28-day mortality when compared with placebo, Dr. Pastores said.
That survival benefit seems to be dependent on several factors: dose of the corticosteroids (hydrocortisone less than 400 mg/day), longer duration (at least 3 or more days), and severity of sepsis. “The more severe the sepsis, the more septic shock the patient was in, the more likely the corticosteroids were likely to help those patients,” Dr. Pastores explained.
Accordingly, the guidelines further suggest using long-course, low-dose corticosteroid treatment, namely intravenous hydrocortisone at no more than 400 mg/day for at least 3 days.
The expert panel specifically recommended hydrocortisone as the corticosteroid of choice in this setting, according to Dr. Pastores. That recommendation was based in part on a recent systematic review and meta-analysis showing that hydrocortisone, given as a bolus or an infusion, was more likely than placebo or methylprednisolone to result in shock reversal.
Dr. Pastores reported disclosures related to Theravance Biopharma, Bayer HealthCare Pharmaceuticals, Spectral Diagnostics, and Asahi-Kasei.
SAN ANTONIO – When corticosteroids are used for septic shock, the dose should be low to moderate, the timing should be early, and the duration should be at least 3 days, said a speaker at the Critical Care Congress sponsored by the Society for Critical Care.
Dosing, timing, and duration are “three critical questions” critical care specialists face that are answered by the new critical illness–related corticosteroid insufficiency (CIRCI) guidelines, continued Stephen M. Pastores, MD, a cochair of the task force that developed guidelines for the diagnosis and management of CIRCI in critically ill patients.
During his presentation, Dr. Pastores limited his remarks to discussion of sepsis and septic shock with corticosteroids. He cautioned that, despite careful deliberations by the panel, the level of evidence behind some of the recommendations was “low to moderate and never high” and that not all task force members agreed with all recommendations.
“There were a lot of back and forth disagreements behind these recommendations,” said Dr. Pastores, who is the director of the critical care medicine fellowship training and research programs at Memorial Sloan Kettering Cancer Center, New York. “We only required 80% of the panelists to agree that these were the recommendations and statements that we were going to go by.”
The guidelines recommend against the use of corticosteroids in adult patients who have sepsis without shock, Dr. Pastores noted.
In contrast,
In an analysis of available data from randomized clinical trials including patients with septic shock, corticosteroids significantly reduced 28-day mortality when compared with placebo, Dr. Pastores said.
That survival benefit seems to be dependent on several factors: dose of the corticosteroids (hydrocortisone less than 400 mg/day), longer duration (at least 3 or more days), and severity of sepsis. “The more severe the sepsis, the more septic shock the patient was in, the more likely the corticosteroids were likely to help those patients,” Dr. Pastores explained.
Accordingly, the guidelines further suggest using long-course, low-dose corticosteroid treatment, namely intravenous hydrocortisone at no more than 400 mg/day for at least 3 days.
The expert panel specifically recommended hydrocortisone as the corticosteroid of choice in this setting, according to Dr. Pastores. That recommendation was based in part on a recent systematic review and meta-analysis showing that hydrocortisone, given as a bolus or an infusion, was more likely than placebo or methylprednisolone to result in shock reversal.
Dr. Pastores reported disclosures related to Theravance Biopharma, Bayer HealthCare Pharmaceuticals, Spectral Diagnostics, and Asahi-Kasei.
EXPERT ANALYSIS FROM THE CCC47
Death rate steady with pediatric early warning system
SAN ANTONIO – , but did not reduce the rate of all-cause hospital mortality, according to results of a large, multicenter trial.
Taken together, the findings of the trial do not support the use of the Bedside Pediatric Early Warning System (BedsidePEWS) to reduce hospital mortality, noted investigator Christopher S. Parshuram, MBChB, DPhil, during a presentation at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
The multicenter randomized cluster study, called the EPOCH trial, included 21 hospitals in seven countries that provided inpatient pediatric care. Ten of the hospitals delivered the BedsidePEWS intervention, while the remaining 11 provided usual care. The study data included 144,539 patient discharges comprising 559,443 patient days. Enrollment began Feb. 28, 2011, and ended on June 21, 2015.
For the BedsidePEWS group, all-cause hospital mortality was 1.93 per 1,000 patient discharges, versus 1.56 per 1,000 patient discharges for usual care (adjusted odds ratio, 1.01; 95% confidence interval, 0.61-1.69; P = .96), according to a report on this study that was published in JAMA.
However, the BedsidePEWS group had a significant improvement in the secondary outcome of significant clinical deterioration events, a composite outcome reflecting late ICU admissions.
In the BedsidePEWS group, the rate of significant clinical deterioration events was 0.50 per 1,000 patient-days, compared with 0.84 per 1,000 patient-days at hospitals with usual care (adjusted rate ratio, 0.77; 95% CI, 0.61-0.97; P = .03), the investigators wrote.
The goal of the EPOCH trial was to determine whether BedsidePEWS could reduce rates of all-cause hospital mortality and significant clinical deterioration among hospitalized children, according to the researchers.
“The BedsidePEWS versus usual care did improve processes of care and early detection of critical illness, aligned with the notion of providing the right care, right now,” Dr. Parshuram, associate professor of critical care medicine and pediatrics at the University of Toronto, said during his presentation at the meeting. “Certainly more vital signs were documented, and anecdotally there were reports of culture change.
“However, when we looked further, there was no difference in hospital mortality, nor hospital resource utilization,” Dr. Parshuram added.
The Canadian Institutes of Health Research funded the study. Dr. Parshuram is an inventor of BedsidePEWS and owns shares in a company that is commercializing it.
SOURCE: Parshuram et al. JAMA. 2018 Feb 27. doi: 10.1001/jama.2018.0948.
SAN ANTONIO – , but did not reduce the rate of all-cause hospital mortality, according to results of a large, multicenter trial.
Taken together, the findings of the trial do not support the use of the Bedside Pediatric Early Warning System (BedsidePEWS) to reduce hospital mortality, noted investigator Christopher S. Parshuram, MBChB, DPhil, during a presentation at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
The multicenter randomized cluster study, called the EPOCH trial, included 21 hospitals in seven countries that provided inpatient pediatric care. Ten of the hospitals delivered the BedsidePEWS intervention, while the remaining 11 provided usual care. The study data included 144,539 patient discharges comprising 559,443 patient days. Enrollment began Feb. 28, 2011, and ended on June 21, 2015.
For the BedsidePEWS group, all-cause hospital mortality was 1.93 per 1,000 patient discharges, versus 1.56 per 1,000 patient discharges for usual care (adjusted odds ratio, 1.01; 95% confidence interval, 0.61-1.69; P = .96), according to a report on this study that was published in JAMA.
However, the BedsidePEWS group had a significant improvement in the secondary outcome of significant clinical deterioration events, a composite outcome reflecting late ICU admissions.
In the BedsidePEWS group, the rate of significant clinical deterioration events was 0.50 per 1,000 patient-days, compared with 0.84 per 1,000 patient-days at hospitals with usual care (adjusted rate ratio, 0.77; 95% CI, 0.61-0.97; P = .03), the investigators wrote.
The goal of the EPOCH trial was to determine whether BedsidePEWS could reduce rates of all-cause hospital mortality and significant clinical deterioration among hospitalized children, according to the researchers.
“The BedsidePEWS versus usual care did improve processes of care and early detection of critical illness, aligned with the notion of providing the right care, right now,” Dr. Parshuram, associate professor of critical care medicine and pediatrics at the University of Toronto, said during his presentation at the meeting. “Certainly more vital signs were documented, and anecdotally there were reports of culture change.
“However, when we looked further, there was no difference in hospital mortality, nor hospital resource utilization,” Dr. Parshuram added.
The Canadian Institutes of Health Research funded the study. Dr. Parshuram is an inventor of BedsidePEWS and owns shares in a company that is commercializing it.
SOURCE: Parshuram et al. JAMA. 2018 Feb 27. doi: 10.1001/jama.2018.0948.
SAN ANTONIO – , but did not reduce the rate of all-cause hospital mortality, according to results of a large, multicenter trial.
Taken together, the findings of the trial do not support the use of the Bedside Pediatric Early Warning System (BedsidePEWS) to reduce hospital mortality, noted investigator Christopher S. Parshuram, MBChB, DPhil, during a presentation at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
The multicenter randomized cluster study, called the EPOCH trial, included 21 hospitals in seven countries that provided inpatient pediatric care. Ten of the hospitals delivered the BedsidePEWS intervention, while the remaining 11 provided usual care. The study data included 144,539 patient discharges comprising 559,443 patient days. Enrollment began Feb. 28, 2011, and ended on June 21, 2015.
For the BedsidePEWS group, all-cause hospital mortality was 1.93 per 1,000 patient discharges, versus 1.56 per 1,000 patient discharges for usual care (adjusted odds ratio, 1.01; 95% confidence interval, 0.61-1.69; P = .96), according to a report on this study that was published in JAMA.
However, the BedsidePEWS group had a significant improvement in the secondary outcome of significant clinical deterioration events, a composite outcome reflecting late ICU admissions.
In the BedsidePEWS group, the rate of significant clinical deterioration events was 0.50 per 1,000 patient-days, compared with 0.84 per 1,000 patient-days at hospitals with usual care (adjusted rate ratio, 0.77; 95% CI, 0.61-0.97; P = .03), the investigators wrote.
The goal of the EPOCH trial was to determine whether BedsidePEWS could reduce rates of all-cause hospital mortality and significant clinical deterioration among hospitalized children, according to the researchers.
“The BedsidePEWS versus usual care did improve processes of care and early detection of critical illness, aligned with the notion of providing the right care, right now,” Dr. Parshuram, associate professor of critical care medicine and pediatrics at the University of Toronto, said during his presentation at the meeting. “Certainly more vital signs were documented, and anecdotally there were reports of culture change.
“However, when we looked further, there was no difference in hospital mortality, nor hospital resource utilization,” Dr. Parshuram added.
The Canadian Institutes of Health Research funded the study. Dr. Parshuram is an inventor of BedsidePEWS and owns shares in a company that is commercializing it.
SOURCE: Parshuram et al. JAMA. 2018 Feb 27. doi: 10.1001/jama.2018.0948.
REPORTING FROM CCC47
Key clinical point: Use of a pediatric early warning system (BedsidePEWS) did not reduce rates of all-cause hospital mortality among hospitalized children, compared with usual care, but did reduce rates of significant clinical deterioration events.
Major finding: For hospitals implementing BedsidePEWS, all-cause hospital mortality was 1.93 per 1,000 patient discharges, versus 1.56 per 1,000 at hospitals with usual care (adjusted odds ratio, 1.01; 95% confidence interval, 0.61-1.69; P = .96).
Study details: A multicenter cluster randomized trial of 144,539 patient discharges from 21 hospitals in seven countries providing pediatric care.
Disclosures: The Canadian Institutes of Health Research funded the study. Dr. Parshuram is an inventor of BedsidePEWS and owns shares in a company that is commercializing it.
Source: Parshuram et al. JAMA. 2018 Feb 27. doi: 10.1001/jama.2018.0948.
Prehospital antibiotics improved some aspects of sepsis care
SAN ANTONIO – according to results of a randomized trial.
Emergency medical service (EMS) personnel were able to recognize sepsis more quickly, obtain blood cultures, and give antibiotics after the training, reported investigator Prabath Nanayakkara, MD, PhD, FRCP, at the Society of Critical Care Medicine’s Critical Care Congress.
At 28 days, 120 patients (8%) in the prehospital antibiotics group had died, compared with 93 patients (8%) in the usual care group (relative risk, 0.95; 95% confidence interval, 0.74-1.24), according to the study’s results that were simultaneously published online in Lancet Respiratory Medicine.
The intervention group received antibiotics a median of 26 minutes prior to emergency department (ED) arrival. In the usual care group, median time to antibiotics after ED arrival was 70 minutes, versus 93 minutes prior to the sepsis recognition training (P = .142), the report further says.
“We do not advise prehospital antibiotics at the moment for patients with suspected sepsis,” Dr. Nanayakkara said, during his presentation at the conference.
Other countries might see different results, he cautioned.
In the Netherlands, ambulances reach the emergency scene within 15 minutes 93% of the time, and the average time from dispatch call to ED arrival is 40 minutes, Dr. Nanayakkara noted in the report.
“In part, due to the relatively short response times in the Netherlands, we don’t know if there are other countries with longer response times that would have other results, and whether they should use antibiotics in their ambulances,” Dr. Nanayakkara said in his presentation.
The study was the first-ever prospective randomized, controlled open-label trial to compare early prehospital antibiotics with standard care.
Before the study was started, EMS personnel at 10 large regional ambulance services serving 34 secondary or tertiary hospitals were trained in recognizing sepsis, the report says.
A total of 2,672 patients with suspected sepsis were included in the intention-to-treat analysis, of whom 1,535 were randomized to receive prehospital antibiotics and 1,137 to usual EMS care, which consisted of fluid resuscitation and supplementary oxygen.
The primary end point of the study was all-cause mortality at 28 days.
The negative mortality results of this trial are “not surprising,” given that the trial’s inclusion criteria allowed individuals with suspected infection but without organ dysfunction, said Jean-Louis Vincent, MD, PhD, of Erasmus Hospital, Brussels, in a related editorial appearing in the Lancet Respiratory Medicine (2018 Jan. doi: 10.1016/S2213-2600[17]30446-0).
Recent consensus definitions of sepsis recognize that sepsis is the association of an infection with some degree of organ dysfunction, according to Dr. Vincent.
“After this initial experience, I believe that a randomized, controlled trial could be done to assess the potential benefit of early antibiotic administration in the ambulance for patients with organ dysfunction associated with infection,” Dr. Vincent wrote in his editorial.
Dr. Nanayakkara and his coauthors declared no competing interests related to their study.
SOURCE: Alam N et al. Lancet Respir Med. 2018 Jan;6(1):40-50.
SAN ANTONIO – according to results of a randomized trial.
Emergency medical service (EMS) personnel were able to recognize sepsis more quickly, obtain blood cultures, and give antibiotics after the training, reported investigator Prabath Nanayakkara, MD, PhD, FRCP, at the Society of Critical Care Medicine’s Critical Care Congress.
At 28 days, 120 patients (8%) in the prehospital antibiotics group had died, compared with 93 patients (8%) in the usual care group (relative risk, 0.95; 95% confidence interval, 0.74-1.24), according to the study’s results that were simultaneously published online in Lancet Respiratory Medicine.
The intervention group received antibiotics a median of 26 minutes prior to emergency department (ED) arrival. In the usual care group, median time to antibiotics after ED arrival was 70 minutes, versus 93 minutes prior to the sepsis recognition training (P = .142), the report further says.
“We do not advise prehospital antibiotics at the moment for patients with suspected sepsis,” Dr. Nanayakkara said, during his presentation at the conference.
Other countries might see different results, he cautioned.
In the Netherlands, ambulances reach the emergency scene within 15 minutes 93% of the time, and the average time from dispatch call to ED arrival is 40 minutes, Dr. Nanayakkara noted in the report.
“In part, due to the relatively short response times in the Netherlands, we don’t know if there are other countries with longer response times that would have other results, and whether they should use antibiotics in their ambulances,” Dr. Nanayakkara said in his presentation.
The study was the first-ever prospective randomized, controlled open-label trial to compare early prehospital antibiotics with standard care.
Before the study was started, EMS personnel at 10 large regional ambulance services serving 34 secondary or tertiary hospitals were trained in recognizing sepsis, the report says.
A total of 2,672 patients with suspected sepsis were included in the intention-to-treat analysis, of whom 1,535 were randomized to receive prehospital antibiotics and 1,137 to usual EMS care, which consisted of fluid resuscitation and supplementary oxygen.
The primary end point of the study was all-cause mortality at 28 days.
The negative mortality results of this trial are “not surprising,” given that the trial’s inclusion criteria allowed individuals with suspected infection but without organ dysfunction, said Jean-Louis Vincent, MD, PhD, of Erasmus Hospital, Brussels, in a related editorial appearing in the Lancet Respiratory Medicine (2018 Jan. doi: 10.1016/S2213-2600[17]30446-0).
Recent consensus definitions of sepsis recognize that sepsis is the association of an infection with some degree of organ dysfunction, according to Dr. Vincent.
“After this initial experience, I believe that a randomized, controlled trial could be done to assess the potential benefit of early antibiotic administration in the ambulance for patients with organ dysfunction associated with infection,” Dr. Vincent wrote in his editorial.
Dr. Nanayakkara and his coauthors declared no competing interests related to their study.
SOURCE: Alam N et al. Lancet Respir Med. 2018 Jan;6(1):40-50.
SAN ANTONIO – according to results of a randomized trial.
Emergency medical service (EMS) personnel were able to recognize sepsis more quickly, obtain blood cultures, and give antibiotics after the training, reported investigator Prabath Nanayakkara, MD, PhD, FRCP, at the Society of Critical Care Medicine’s Critical Care Congress.
At 28 days, 120 patients (8%) in the prehospital antibiotics group had died, compared with 93 patients (8%) in the usual care group (relative risk, 0.95; 95% confidence interval, 0.74-1.24), according to the study’s results that were simultaneously published online in Lancet Respiratory Medicine.
The intervention group received antibiotics a median of 26 minutes prior to emergency department (ED) arrival. In the usual care group, median time to antibiotics after ED arrival was 70 minutes, versus 93 minutes prior to the sepsis recognition training (P = .142), the report further says.
“We do not advise prehospital antibiotics at the moment for patients with suspected sepsis,” Dr. Nanayakkara said, during his presentation at the conference.
Other countries might see different results, he cautioned.
In the Netherlands, ambulances reach the emergency scene within 15 minutes 93% of the time, and the average time from dispatch call to ED arrival is 40 minutes, Dr. Nanayakkara noted in the report.
“In part, due to the relatively short response times in the Netherlands, we don’t know if there are other countries with longer response times that would have other results, and whether they should use antibiotics in their ambulances,” Dr. Nanayakkara said in his presentation.
The study was the first-ever prospective randomized, controlled open-label trial to compare early prehospital antibiotics with standard care.
Before the study was started, EMS personnel at 10 large regional ambulance services serving 34 secondary or tertiary hospitals were trained in recognizing sepsis, the report says.
A total of 2,672 patients with suspected sepsis were included in the intention-to-treat analysis, of whom 1,535 were randomized to receive prehospital antibiotics and 1,137 to usual EMS care, which consisted of fluid resuscitation and supplementary oxygen.
The primary end point of the study was all-cause mortality at 28 days.
The negative mortality results of this trial are “not surprising,” given that the trial’s inclusion criteria allowed individuals with suspected infection but without organ dysfunction, said Jean-Louis Vincent, MD, PhD, of Erasmus Hospital, Brussels, in a related editorial appearing in the Lancet Respiratory Medicine (2018 Jan. doi: 10.1016/S2213-2600[17]30446-0).
Recent consensus definitions of sepsis recognize that sepsis is the association of an infection with some degree of organ dysfunction, according to Dr. Vincent.
“After this initial experience, I believe that a randomized, controlled trial could be done to assess the potential benefit of early antibiotic administration in the ambulance for patients with organ dysfunction associated with infection,” Dr. Vincent wrote in his editorial.
Dr. Nanayakkara and his coauthors declared no competing interests related to their study.
SOURCE: Alam N et al. Lancet Respir Med. 2018 Jan;6(1):40-50.
REPORTING FROM CCC47
Key clinical point: In patients with suspected sepsis, prehospital antibiotics delivered by EMS personnel improved some aspects of care, but did not reduce mortality.
Major finding: At 28 days, 120 patients (8%) in the prehospital antibiotics group had died, compared with 93 patients (8%) in the usual care group (relative risk, 0.95; 95% CI, 0.74-1.24).
Data source: Intention-to-treat analysis of 2,672 patients in a prospective randomized, controlled open-label trial comparing early prehospital antibiotics to standard care.
Disclosures: The study authors declared no competing interests related to the study.
Source: Alam N et al. Lancet Respir Med. 2018 Jan;6(1):40-50.
Preparing to respond to workplace violence
SAN ANTONIO – , Lewis J. Kaplan, MD, said in a late-breaking session at the Critical Care Congress.
“Workplace violence is not just active shooter – it’s ubiquitous, and we only know a little bit about it,” noted Dr. Kaplan, section chief, surgical critical care, Corporal Michael J. Crescenz VA Medical Center, Philadelphia. “The facility and everyone in the health care team have a role in being an active participant, rather than a passive one.”
To actively prepare for premeditated events, Dr. Kaplan recommended that clinicians develop partnerships with local law enforcement officials and initiate active training that involves anyone who could come into contact with an active shooter.
There are many steps that can be taken to protect the facility, including visitor screening and management, security that extends to the perimeter of the facility, building design that limits access to specific places in the facility, and deployment of firearm detection canines, Dr. Kaplan said, during the session at the Critical Care Congress, sponsored by the Society of Critical Care Medicine.
In all, Dr. Kaplan listed 19 steps that facilities could take to avert a planned attack, drawing in part on recommendations from the FBI publication, Workplace violence: Issues in response.
“This is a lot, and you don’t need to do all of it,” Dr. Kaplan said. “But you need to have an internally consistent plan for how you will do this at your facility, and it must involve everyone. They all need to be able to be part of your team.”
Recent data on workplace violence
The latest data show that the great majority of workplace violence is perpetrated by individuals outside the organization. According to the IAHSS Foundation 2017 Healthcare Crime Survey, 89% of events involved a customer or patient of the workplace or employees.
In-hospital violence is prevalent, according to 2016 data from Occupational Safety and Health Administration that identified 24,000 workplace assaults in a 3-year span covering 2013-2015, including 33 homicides, 30 assaults, and 74 rapes.
Many in-hospital incidents are marked by failures in communication, patient observation, noncompliance with workplace violence policies or lack of such policies, and perhaps most importantly, an inadequate assessment for the violent potential of the perpetrator, according to Dr. Kaplan.
In a 2017 survey of 150 trauma nurses, 67% said they had been the victim of physical violence at work, though many did not report the incidents, Dr. Kaplan noted. Some reasons nurses gave for not reporting violence included the feeling that it was “just part of the job” in 27% of cases, and concerns about patient satisfaction scores in 10% of the cases.
Active shooter events in the workplace are of particular concern, though they are relatively rare; one recent report identified 160 events that occurred during 2000-2013 in which 1,043 individuals were injured, according to Dr. Kaplan.
Other presentations in the late-breaking session covered issues related to disaster preparedness and the Charlie Gard case.
“We picked these three topics to be in a late-breaker session not only because of the recent events that had happened, but because they have a common thread – it’s not a matter of if it will happen, but when will it happen, and are you ready and how do we prepare,” said session chair Gloria M. Rodriguez Vega, MD.
“One of the things I learned as a fellow was that part of the success in critical care was attention to detail and layers of safety,” said Dr. Rodriguez Vega, an intensivist in Bayamon, Puerto Rico. “I think you can apply that to all these situations.”
Dr. Kaplan had no industry disclosures related to his presentation.
SAN ANTONIO – , Lewis J. Kaplan, MD, said in a late-breaking session at the Critical Care Congress.
“Workplace violence is not just active shooter – it’s ubiquitous, and we only know a little bit about it,” noted Dr. Kaplan, section chief, surgical critical care, Corporal Michael J. Crescenz VA Medical Center, Philadelphia. “The facility and everyone in the health care team have a role in being an active participant, rather than a passive one.”
To actively prepare for premeditated events, Dr. Kaplan recommended that clinicians develop partnerships with local law enforcement officials and initiate active training that involves anyone who could come into contact with an active shooter.
There are many steps that can be taken to protect the facility, including visitor screening and management, security that extends to the perimeter of the facility, building design that limits access to specific places in the facility, and deployment of firearm detection canines, Dr. Kaplan said, during the session at the Critical Care Congress, sponsored by the Society of Critical Care Medicine.
In all, Dr. Kaplan listed 19 steps that facilities could take to avert a planned attack, drawing in part on recommendations from the FBI publication, Workplace violence: Issues in response.
“This is a lot, and you don’t need to do all of it,” Dr. Kaplan said. “But you need to have an internally consistent plan for how you will do this at your facility, and it must involve everyone. They all need to be able to be part of your team.”
Recent data on workplace violence
The latest data show that the great majority of workplace violence is perpetrated by individuals outside the organization. According to the IAHSS Foundation 2017 Healthcare Crime Survey, 89% of events involved a customer or patient of the workplace or employees.
In-hospital violence is prevalent, according to 2016 data from Occupational Safety and Health Administration that identified 24,000 workplace assaults in a 3-year span covering 2013-2015, including 33 homicides, 30 assaults, and 74 rapes.
Many in-hospital incidents are marked by failures in communication, patient observation, noncompliance with workplace violence policies or lack of such policies, and perhaps most importantly, an inadequate assessment for the violent potential of the perpetrator, according to Dr. Kaplan.
In a 2017 survey of 150 trauma nurses, 67% said they had been the victim of physical violence at work, though many did not report the incidents, Dr. Kaplan noted. Some reasons nurses gave for not reporting violence included the feeling that it was “just part of the job” in 27% of cases, and concerns about patient satisfaction scores in 10% of the cases.
Active shooter events in the workplace are of particular concern, though they are relatively rare; one recent report identified 160 events that occurred during 2000-2013 in which 1,043 individuals were injured, according to Dr. Kaplan.
Other presentations in the late-breaking session covered issues related to disaster preparedness and the Charlie Gard case.
“We picked these three topics to be in a late-breaker session not only because of the recent events that had happened, but because they have a common thread – it’s not a matter of if it will happen, but when will it happen, and are you ready and how do we prepare,” said session chair Gloria M. Rodriguez Vega, MD.
“One of the things I learned as a fellow was that part of the success in critical care was attention to detail and layers of safety,” said Dr. Rodriguez Vega, an intensivist in Bayamon, Puerto Rico. “I think you can apply that to all these situations.”
Dr. Kaplan had no industry disclosures related to his presentation.
SAN ANTONIO – , Lewis J. Kaplan, MD, said in a late-breaking session at the Critical Care Congress.
“Workplace violence is not just active shooter – it’s ubiquitous, and we only know a little bit about it,” noted Dr. Kaplan, section chief, surgical critical care, Corporal Michael J. Crescenz VA Medical Center, Philadelphia. “The facility and everyone in the health care team have a role in being an active participant, rather than a passive one.”
To actively prepare for premeditated events, Dr. Kaplan recommended that clinicians develop partnerships with local law enforcement officials and initiate active training that involves anyone who could come into contact with an active shooter.
There are many steps that can be taken to protect the facility, including visitor screening and management, security that extends to the perimeter of the facility, building design that limits access to specific places in the facility, and deployment of firearm detection canines, Dr. Kaplan said, during the session at the Critical Care Congress, sponsored by the Society of Critical Care Medicine.
In all, Dr. Kaplan listed 19 steps that facilities could take to avert a planned attack, drawing in part on recommendations from the FBI publication, Workplace violence: Issues in response.
“This is a lot, and you don’t need to do all of it,” Dr. Kaplan said. “But you need to have an internally consistent plan for how you will do this at your facility, and it must involve everyone. They all need to be able to be part of your team.”
Recent data on workplace violence
The latest data show that the great majority of workplace violence is perpetrated by individuals outside the organization. According to the IAHSS Foundation 2017 Healthcare Crime Survey, 89% of events involved a customer or patient of the workplace or employees.
In-hospital violence is prevalent, according to 2016 data from Occupational Safety and Health Administration that identified 24,000 workplace assaults in a 3-year span covering 2013-2015, including 33 homicides, 30 assaults, and 74 rapes.
Many in-hospital incidents are marked by failures in communication, patient observation, noncompliance with workplace violence policies or lack of such policies, and perhaps most importantly, an inadequate assessment for the violent potential of the perpetrator, according to Dr. Kaplan.
In a 2017 survey of 150 trauma nurses, 67% said they had been the victim of physical violence at work, though many did not report the incidents, Dr. Kaplan noted. Some reasons nurses gave for not reporting violence included the feeling that it was “just part of the job” in 27% of cases, and concerns about patient satisfaction scores in 10% of the cases.
Active shooter events in the workplace are of particular concern, though they are relatively rare; one recent report identified 160 events that occurred during 2000-2013 in which 1,043 individuals were injured, according to Dr. Kaplan.
Other presentations in the late-breaking session covered issues related to disaster preparedness and the Charlie Gard case.
“We picked these three topics to be in a late-breaker session not only because of the recent events that had happened, but because they have a common thread – it’s not a matter of if it will happen, but when will it happen, and are you ready and how do we prepare,” said session chair Gloria M. Rodriguez Vega, MD.
“One of the things I learned as a fellow was that part of the success in critical care was attention to detail and layers of safety,” said Dr. Rodriguez Vega, an intensivist in Bayamon, Puerto Rico. “I think you can apply that to all these situations.”
Dr. Kaplan had no industry disclosures related to his presentation.
REPORTING FROM CCC47
Intermittent dosing cuts time to extubation for surgical patients
SAN ANTONIO – according to a preliminary analysis of a randomized trial.
Additionally, the researchers found that much lower amounts of sedation and analgesia were given to patients who underwent intermittent dosing, compared with patients who received a continuous infusion.
Of the 95 patients in the trial, 39 were randomized to intermittent dosing and 56 to the control group of continuous infusion, with the drugs midazolam and fentanyl having been given to both groups.
Mean mechanical ventilation time was 65 hours in the intermittent dosing arm, versus 111 hours in the continuous infusion arm (P less than 0.03), noted Dr. Sich, a fourth-year general surgery resident at Abington Memorial Hospital, Abington, Pa., during his presentation.
Patients in the continuous infusions arm of the trial received a mean of 73.1 mg of midazolam, compared with 18 mg for the intermittent dosing arm, a difference that approached very closely to statistical significance (P = 0.06) and was thrown off in the latest iteration by an outlier, Dr. Sich explained. The relative difference between the mean fentanyl doses administered was even greater between the two groups, with 5,848 mcg given to patients in the control group, versus the 942 mcg given to participants in the intermittent dosing group (P less than 0.01).
“This is a new way to use an old drug, and it really might be beneficial, and can even be used as first-line therapy and a way to keep patients awake and off the ventilator,” said Dr. Sich, referring to the intermittent dosing. Continuous infusions leave patients oversedated and prolong ventilation time.
“What we propose, rather, is using a sliding-scale intermittent pain and sedation regimen,” he said. “We believe that it won’t compromise patient care and won’t compromise patient comfort, and it will lead to shorter mechanical ventilation times for surgical patients than continuous infusions.”
Dr. Sich also pointed out that there was no difference in time spent at target levels of sedation and analgesia between the two trial groups. Referring to this finding, he noted that “we wanted to make sure that in the intermittent arm we’re giving them less drug, but we don’t want them to be [less comfortable].”
One potential drawback to the intermittent dosing approach is that it is more nursing intensive, according to Dr. Sich, since it is based on a nursing treatment protocol to give medications every hour.
Intermittent dosing is “more hands-on” than a typical continuous infusion approach and so was more challenging for nurses who, per the treatment protocol, had to give medications every hour, he explained. However, “when they saw the data in the months and year as we’ve been going on, they’re actually quite proud of our work and their work.”
Gilman Baker Allen, MD, a pulmonologist and intensivist at the University of Vermont Medical Center, Burlington, said the study was “terrific work” and acknowledged the importance of gauging nurse satisfaction with the protocol.
“I think that when you feed this kind of data back to nursing staff, they may not be satisfied with the intensity of the work, but when they see the rewards at the end, it oftentimes is a very positive experience,” said Dr. Allen, who moderated the session.
Dr. Sich and his colleagues had no financial disclosures or conflicts of interest related to the study.
SOURCE: Sich N et al. CCC47, Abstract 18.
SAN ANTONIO – according to a preliminary analysis of a randomized trial.
Additionally, the researchers found that much lower amounts of sedation and analgesia were given to patients who underwent intermittent dosing, compared with patients who received a continuous infusion.
Of the 95 patients in the trial, 39 were randomized to intermittent dosing and 56 to the control group of continuous infusion, with the drugs midazolam and fentanyl having been given to both groups.
Mean mechanical ventilation time was 65 hours in the intermittent dosing arm, versus 111 hours in the continuous infusion arm (P less than 0.03), noted Dr. Sich, a fourth-year general surgery resident at Abington Memorial Hospital, Abington, Pa., during his presentation.
Patients in the continuous infusions arm of the trial received a mean of 73.1 mg of midazolam, compared with 18 mg for the intermittent dosing arm, a difference that approached very closely to statistical significance (P = 0.06) and was thrown off in the latest iteration by an outlier, Dr. Sich explained. The relative difference between the mean fentanyl doses administered was even greater between the two groups, with 5,848 mcg given to patients in the control group, versus the 942 mcg given to participants in the intermittent dosing group (P less than 0.01).
“This is a new way to use an old drug, and it really might be beneficial, and can even be used as first-line therapy and a way to keep patients awake and off the ventilator,” said Dr. Sich, referring to the intermittent dosing. Continuous infusions leave patients oversedated and prolong ventilation time.
“What we propose, rather, is using a sliding-scale intermittent pain and sedation regimen,” he said. “We believe that it won’t compromise patient care and won’t compromise patient comfort, and it will lead to shorter mechanical ventilation times for surgical patients than continuous infusions.”
Dr. Sich also pointed out that there was no difference in time spent at target levels of sedation and analgesia between the two trial groups. Referring to this finding, he noted that “we wanted to make sure that in the intermittent arm we’re giving them less drug, but we don’t want them to be [less comfortable].”
One potential drawback to the intermittent dosing approach is that it is more nursing intensive, according to Dr. Sich, since it is based on a nursing treatment protocol to give medications every hour.
Intermittent dosing is “more hands-on” than a typical continuous infusion approach and so was more challenging for nurses who, per the treatment protocol, had to give medications every hour, he explained. However, “when they saw the data in the months and year as we’ve been going on, they’re actually quite proud of our work and their work.”
Gilman Baker Allen, MD, a pulmonologist and intensivist at the University of Vermont Medical Center, Burlington, said the study was “terrific work” and acknowledged the importance of gauging nurse satisfaction with the protocol.
“I think that when you feed this kind of data back to nursing staff, they may not be satisfied with the intensity of the work, but when they see the rewards at the end, it oftentimes is a very positive experience,” said Dr. Allen, who moderated the session.
Dr. Sich and his colleagues had no financial disclosures or conflicts of interest related to the study.
SOURCE: Sich N et al. CCC47, Abstract 18.
SAN ANTONIO – according to a preliminary analysis of a randomized trial.
Additionally, the researchers found that much lower amounts of sedation and analgesia were given to patients who underwent intermittent dosing, compared with patients who received a continuous infusion.
Of the 95 patients in the trial, 39 were randomized to intermittent dosing and 56 to the control group of continuous infusion, with the drugs midazolam and fentanyl having been given to both groups.
Mean mechanical ventilation time was 65 hours in the intermittent dosing arm, versus 111 hours in the continuous infusion arm (P less than 0.03), noted Dr. Sich, a fourth-year general surgery resident at Abington Memorial Hospital, Abington, Pa., during his presentation.
Patients in the continuous infusions arm of the trial received a mean of 73.1 mg of midazolam, compared with 18 mg for the intermittent dosing arm, a difference that approached very closely to statistical significance (P = 0.06) and was thrown off in the latest iteration by an outlier, Dr. Sich explained. The relative difference between the mean fentanyl doses administered was even greater between the two groups, with 5,848 mcg given to patients in the control group, versus the 942 mcg given to participants in the intermittent dosing group (P less than 0.01).
“This is a new way to use an old drug, and it really might be beneficial, and can even be used as first-line therapy and a way to keep patients awake and off the ventilator,” said Dr. Sich, referring to the intermittent dosing. Continuous infusions leave patients oversedated and prolong ventilation time.
“What we propose, rather, is using a sliding-scale intermittent pain and sedation regimen,” he said. “We believe that it won’t compromise patient care and won’t compromise patient comfort, and it will lead to shorter mechanical ventilation times for surgical patients than continuous infusions.”
Dr. Sich also pointed out that there was no difference in time spent at target levels of sedation and analgesia between the two trial groups. Referring to this finding, he noted that “we wanted to make sure that in the intermittent arm we’re giving them less drug, but we don’t want them to be [less comfortable].”
One potential drawback to the intermittent dosing approach is that it is more nursing intensive, according to Dr. Sich, since it is based on a nursing treatment protocol to give medications every hour.
Intermittent dosing is “more hands-on” than a typical continuous infusion approach and so was more challenging for nurses who, per the treatment protocol, had to give medications every hour, he explained. However, “when they saw the data in the months and year as we’ve been going on, they’re actually quite proud of our work and their work.”
Gilman Baker Allen, MD, a pulmonologist and intensivist at the University of Vermont Medical Center, Burlington, said the study was “terrific work” and acknowledged the importance of gauging nurse satisfaction with the protocol.
“I think that when you feed this kind of data back to nursing staff, they may not be satisfied with the intensity of the work, but when they see the rewards at the end, it oftentimes is a very positive experience,” said Dr. Allen, who moderated the session.
Dr. Sich and his colleagues had no financial disclosures or conflicts of interest related to the study.
SOURCE: Sich N et al. CCC47, Abstract 18.
Reporting from CCC47
Key clinical point: Among patients requiring ventilation, intermittent administration of sedation and analgesia significantly reduced mechanical ventilation time and total amount of drugs versus a continuous infusion approach.
Major finding: Mean mechanical ventilation time was 65 hours in the intermittent dosing arm, versus 111 hours in the continuous infusion arm (P less than 0.03).
Data source: A single-blinded, randomized, controlled trial of 95 surgical patients requiring ventilation.
Disclosures: The authors reported no financial disclosures or conflicts of interest related to the study.
Source: Sich N et al. CCC47, Abstract 18.
On-demand nebulization in ICU equivalent to standard
SAN ANTONIO – with both medications, according to the results of a randomized clinical trial presented by Frederique Paulus, RN, PhD.
In this study, adverse events such as tachyarrhythmia and agitation were less frequent with the on-demand approach, in which patients receive nebulization based on strict clinical indications, Dr. Paulus reported at the Critical Care Congress sponsored by the Society for Critical Care Medicine. The study was published simultaneously in JAMA.
The on-demand approach may also be cost saving, she noted, citing an economic analysis underway that is not yet ready for publication.
“In our ICU, it will save us 350,000 Euros a year,” she said. “In the Netherlands, 40,000 patients will be mechanically ventilated in a year, so it will save us millions in the Netherlands alone.”
The study included adult ICU patients who were expected not to be extubated for at least 24 hours. Dr. Paulus presented the primary analysis of the study, which included data for 922 patients who were randomized either to the on-demand group (n = 455) or the routine nebulization group (n = 467) and completed follow-up.
Patients assigned to the on-demand group received acetylcysteine-containing solutions if they had thick or tenacious secretions, or salbutamol-containing solutions if wheezing was observed or suspected or when findings were suggestive of lower-airway obstruction, according to the paper, published in JAMA.
The primary outcome, number of ventilator-free days at day 28 of the study, was noninferior in the on-demand group versus the routine group, Dr. Paulus said.
The median number of ventilator-free days was 21 for the on-demand group and 20 for the routine group, said the paper.
The length of stay, mortality, and proportion of patients developing pulmonary complications did not differ between the two study arms, the investigators also reported in JAMA.
However, adverse events occurred in just 13.8% of the on-demand group, compared with 29.3% of the routine group (P less than .001), with the difference in adverse events mainly attributable to less tachyarrhythmia and agitation in the experimental group, according to the researchers.
Dr. Paulus and coauthors reported no conflicts of interest related to the study.
SOURCE: Paulus F et al. (van Meenen DMP et al.) JAMA. 2018 Feb. doi: 10.1001/jama.2018.0949.
I would suspect local practice patterns with nebulized acytylcysteine to vary even more widely than bronchodilator administration strategies.
I would suspect local practice patterns with nebulized acytylcysteine to vary even more widely than bronchodilator administration strategies.
I would suspect local practice patterns with nebulized acytylcysteine to vary even more widely than bronchodilator administration strategies.
SAN ANTONIO – with both medications, according to the results of a randomized clinical trial presented by Frederique Paulus, RN, PhD.
In this study, adverse events such as tachyarrhythmia and agitation were less frequent with the on-demand approach, in which patients receive nebulization based on strict clinical indications, Dr. Paulus reported at the Critical Care Congress sponsored by the Society for Critical Care Medicine. The study was published simultaneously in JAMA.
The on-demand approach may also be cost saving, she noted, citing an economic analysis underway that is not yet ready for publication.
“In our ICU, it will save us 350,000 Euros a year,” she said. “In the Netherlands, 40,000 patients will be mechanically ventilated in a year, so it will save us millions in the Netherlands alone.”
The study included adult ICU patients who were expected not to be extubated for at least 24 hours. Dr. Paulus presented the primary analysis of the study, which included data for 922 patients who were randomized either to the on-demand group (n = 455) or the routine nebulization group (n = 467) and completed follow-up.
Patients assigned to the on-demand group received acetylcysteine-containing solutions if they had thick or tenacious secretions, or salbutamol-containing solutions if wheezing was observed or suspected or when findings were suggestive of lower-airway obstruction, according to the paper, published in JAMA.
The primary outcome, number of ventilator-free days at day 28 of the study, was noninferior in the on-demand group versus the routine group, Dr. Paulus said.
The median number of ventilator-free days was 21 for the on-demand group and 20 for the routine group, said the paper.
The length of stay, mortality, and proportion of patients developing pulmonary complications did not differ between the two study arms, the investigators also reported in JAMA.
However, adverse events occurred in just 13.8% of the on-demand group, compared with 29.3% of the routine group (P less than .001), with the difference in adverse events mainly attributable to less tachyarrhythmia and agitation in the experimental group, according to the researchers.
Dr. Paulus and coauthors reported no conflicts of interest related to the study.
SOURCE: Paulus F et al. (van Meenen DMP et al.) JAMA. 2018 Feb. doi: 10.1001/jama.2018.0949.
SAN ANTONIO – with both medications, according to the results of a randomized clinical trial presented by Frederique Paulus, RN, PhD.
In this study, adverse events such as tachyarrhythmia and agitation were less frequent with the on-demand approach, in which patients receive nebulization based on strict clinical indications, Dr. Paulus reported at the Critical Care Congress sponsored by the Society for Critical Care Medicine. The study was published simultaneously in JAMA.
The on-demand approach may also be cost saving, she noted, citing an economic analysis underway that is not yet ready for publication.
“In our ICU, it will save us 350,000 Euros a year,” she said. “In the Netherlands, 40,000 patients will be mechanically ventilated in a year, so it will save us millions in the Netherlands alone.”
The study included adult ICU patients who were expected not to be extubated for at least 24 hours. Dr. Paulus presented the primary analysis of the study, which included data for 922 patients who were randomized either to the on-demand group (n = 455) or the routine nebulization group (n = 467) and completed follow-up.
Patients assigned to the on-demand group received acetylcysteine-containing solutions if they had thick or tenacious secretions, or salbutamol-containing solutions if wheezing was observed or suspected or when findings were suggestive of lower-airway obstruction, according to the paper, published in JAMA.
The primary outcome, number of ventilator-free days at day 28 of the study, was noninferior in the on-demand group versus the routine group, Dr. Paulus said.
The median number of ventilator-free days was 21 for the on-demand group and 20 for the routine group, said the paper.
The length of stay, mortality, and proportion of patients developing pulmonary complications did not differ between the two study arms, the investigators also reported in JAMA.
However, adverse events occurred in just 13.8% of the on-demand group, compared with 29.3% of the routine group (P less than .001), with the difference in adverse events mainly attributable to less tachyarrhythmia and agitation in the experimental group, according to the researchers.
Dr. Paulus and coauthors reported no conflicts of interest related to the study.
SOURCE: Paulus F et al. (van Meenen DMP et al.) JAMA. 2018 Feb. doi: 10.1001/jama.2018.0949.
REPORTING FROM CCC47
Key clinical point: Compared with routine nebulization with acetylcysteine or salbutamol, on-demand nebulization with acetylcysteine or salbutamol was noninferior among patients receiving invasive ventilation in the ICU.
Major finding: At day 28, the median number of ventilator-free days was 21 in the on-demand group and 20 in the routine care group.
Data source: Primary analysis of a randomized clinical trial including 922 adult patients who were expected to need at least 24 hours of invasive ventilation at one of seven ICUs in the Netherlands.
Disclosures: Authors reported no conflicts of interest related to the study.
Source: Paulus F et al. (van Meenen DMP et al.) JAMA. 2018 Feb. doi: 10.1001/jama.2018.0949.
Increasing sepsis survivorship creates new challenges
SAN ANTONIO – , results of a retrospective, single-center analysis suggest.
The number of sepsis survivors at risk for hospital readmission rose substantially in recent years, according to the analysis of 17,256 adult medical and surgical admissions to University of Pennsylvania Health System hospitals between July 1, 2010, and June 30, 2015. The journal Critical Care Medicine published these results online as Mark E. Mikkelsen, MD, was presenting them at the Critical Care Congress sponsored by the Society for Critical Care Medicine.
Over the time period that Dr. Mikkelsen and his colleagues analyzed, the proportion of sepsis hospitalizations more than doubled from 3.9% to 9.4%, while in-hospital mortality rates for sepsis hospitalizations fell from 24.1% to 14.8%. As a result, the proportion of discharged patients at risk for readmission increased from 2.7% to 7.8%, noted Dr. Mikkelsen, associate professor of medicine at the Hospital of the University Of Pennsylvania, Philadelphia.
Thirty-day hospital readmission rates modestly declined from 26.4% to 23.1% over that time period, driven by reduced readmissions among survivors of nonsevere and nonpneumonia sepsis, Dr. Mikkelsen said. This decline in overall sepsis patient readmissions was offset by an increase in emergency department treat-and-release visits. Such visits rose from 2.8% in 2010 to a peak of 5.4% in 2014, Dr. Mikkelsen explained. Generally, readmission rates for severe sepsis patients have not changed over time, he added.
“I anticipate that each and every hospital represented in this room will experience a similar phenomenon,” he said. “Therefore, high quality postdischarge care is in fact urgently needed,” he added. “It is warranted that there is an international spotlight on sepsis beginning in the hospital but now continuing thereafter into the phase of life after sepsis.”
These findings reflect “great sepsis survivorship” and suggest new challenges to address, said Timothy G. Buchman, MD, PhD, editor-in-chief of the Critical Care Medicine and past president of the Society for Critical Care Medicine.
“It’s really extraordinary to see that the efforts that have been made by the Surviving Sepsis campaign have paid off,” Dr. Buchman said in an interview. “Now we need to look much more carefully at both the readmission issues, as well as the consequences of long-term sepsis survivorship, not just on patients, but also on their families.”
Dr. Mikkelsen and a study coauthor received support for article research from the National Institutes of Health.
SOURCE: Meyer N et al. Crit Care Med. 2018 Mar. doi: 10.1097/CCM. 0000000000002872.
SAN ANTONIO – , results of a retrospective, single-center analysis suggest.
The number of sepsis survivors at risk for hospital readmission rose substantially in recent years, according to the analysis of 17,256 adult medical and surgical admissions to University of Pennsylvania Health System hospitals between July 1, 2010, and June 30, 2015. The journal Critical Care Medicine published these results online as Mark E. Mikkelsen, MD, was presenting them at the Critical Care Congress sponsored by the Society for Critical Care Medicine.
Over the time period that Dr. Mikkelsen and his colleagues analyzed, the proportion of sepsis hospitalizations more than doubled from 3.9% to 9.4%, while in-hospital mortality rates for sepsis hospitalizations fell from 24.1% to 14.8%. As a result, the proportion of discharged patients at risk for readmission increased from 2.7% to 7.8%, noted Dr. Mikkelsen, associate professor of medicine at the Hospital of the University Of Pennsylvania, Philadelphia.
Thirty-day hospital readmission rates modestly declined from 26.4% to 23.1% over that time period, driven by reduced readmissions among survivors of nonsevere and nonpneumonia sepsis, Dr. Mikkelsen said. This decline in overall sepsis patient readmissions was offset by an increase in emergency department treat-and-release visits. Such visits rose from 2.8% in 2010 to a peak of 5.4% in 2014, Dr. Mikkelsen explained. Generally, readmission rates for severe sepsis patients have not changed over time, he added.
“I anticipate that each and every hospital represented in this room will experience a similar phenomenon,” he said. “Therefore, high quality postdischarge care is in fact urgently needed,” he added. “It is warranted that there is an international spotlight on sepsis beginning in the hospital but now continuing thereafter into the phase of life after sepsis.”
These findings reflect “great sepsis survivorship” and suggest new challenges to address, said Timothy G. Buchman, MD, PhD, editor-in-chief of the Critical Care Medicine and past president of the Society for Critical Care Medicine.
“It’s really extraordinary to see that the efforts that have been made by the Surviving Sepsis campaign have paid off,” Dr. Buchman said in an interview. “Now we need to look much more carefully at both the readmission issues, as well as the consequences of long-term sepsis survivorship, not just on patients, but also on their families.”
Dr. Mikkelsen and a study coauthor received support for article research from the National Institutes of Health.
SOURCE: Meyer N et al. Crit Care Med. 2018 Mar. doi: 10.1097/CCM. 0000000000002872.
SAN ANTONIO – , results of a retrospective, single-center analysis suggest.
The number of sepsis survivors at risk for hospital readmission rose substantially in recent years, according to the analysis of 17,256 adult medical and surgical admissions to University of Pennsylvania Health System hospitals between July 1, 2010, and June 30, 2015. The journal Critical Care Medicine published these results online as Mark E. Mikkelsen, MD, was presenting them at the Critical Care Congress sponsored by the Society for Critical Care Medicine.
Over the time period that Dr. Mikkelsen and his colleagues analyzed, the proportion of sepsis hospitalizations more than doubled from 3.9% to 9.4%, while in-hospital mortality rates for sepsis hospitalizations fell from 24.1% to 14.8%. As a result, the proportion of discharged patients at risk for readmission increased from 2.7% to 7.8%, noted Dr. Mikkelsen, associate professor of medicine at the Hospital of the University Of Pennsylvania, Philadelphia.
Thirty-day hospital readmission rates modestly declined from 26.4% to 23.1% over that time period, driven by reduced readmissions among survivors of nonsevere and nonpneumonia sepsis, Dr. Mikkelsen said. This decline in overall sepsis patient readmissions was offset by an increase in emergency department treat-and-release visits. Such visits rose from 2.8% in 2010 to a peak of 5.4% in 2014, Dr. Mikkelsen explained. Generally, readmission rates for severe sepsis patients have not changed over time, he added.
“I anticipate that each and every hospital represented in this room will experience a similar phenomenon,” he said. “Therefore, high quality postdischarge care is in fact urgently needed,” he added. “It is warranted that there is an international spotlight on sepsis beginning in the hospital but now continuing thereafter into the phase of life after sepsis.”
These findings reflect “great sepsis survivorship” and suggest new challenges to address, said Timothy G. Buchman, MD, PhD, editor-in-chief of the Critical Care Medicine and past president of the Society for Critical Care Medicine.
“It’s really extraordinary to see that the efforts that have been made by the Surviving Sepsis campaign have paid off,” Dr. Buchman said in an interview. “Now we need to look much more carefully at both the readmission issues, as well as the consequences of long-term sepsis survivorship, not just on patients, but also on their families.”
Dr. Mikkelsen and a study coauthor received support for article research from the National Institutes of Health.
SOURCE: Meyer N et al. Crit Care Med. 2018 Mar. doi: 10.1097/CCM. 0000000000002872.
AT CCC47
Key clinical point: An analysis of one center’s sepsis cases revealed increases in sepsis survivors at risk for hospital readmission and returns of these patients to the hospital via the emergency department.
Major finding: The proportion of medical and surgical discharges at risk for hospital readmission after sepsis grew from 2.7% to 7.8%. The modest decline in 30-day readmission rates was offset by an increase in emergency department treat-and-release visits.
Data source: A retrospective, observational cohort study of more than 17,000 adult medical and surgical admissions in an academic health care system from 2010 to 2015.
Disclosures: The National Institutes of Health supported the work.
Source: Meyer N et al. Crit Care Med. 2018 Mar. doi: 10.1097/CCM.0000000000002872.
Dexmedetomidine: ‘Silver bullet’ for ventilator liberation?
SAN ANTONIO – Among medications to facilitate extubation, dexmedetomidine offers favorable attributes, but whether it’s the best choice for patients who have difficulty being liberated from the ventilator remains to be proven, said Gilles L. Fraser, BS Pharm, PharmD.
The current CHEST/ATS guidelines on liberation from mechanical ventilation in critically ill adults strongly suggest extubation to noninvasive mechanical ventilation in high-risk patients (Chest. 2017 Jan;151[1]:160-5. doi: 10.1016/j.chest.2016.10.037). Guideline authors also suggested protocols attempting to minimize sedation for acutely hospitalized patients ventilated for more than 24 hours, based on some evidence showing a trend toward shorter ventilation time and ICU stay, as well as lower short-term mortality.
, one of the coauthors of the guidelines, during his presentation at the Critical Care Congress sponsored by the Society for Critical Care Medicine.
“I’ll leave you up to your own devices,” he told attendees at a session on conundrums in critical care that are not addressed in current guidelines. “We use it all the time, frankly, but I don’t have any firm data to support that contention.”
Despite best practices, extubation attempts are not always successful: “If you follow the rules of the road, success is going to occur about 85% of the time,” said Dr. Fraser, who is a clinical pharmacist at Maine Medical Center, Portland, and professor of medicine at Tufts University, Boston. “That means that about 15% of our patients have difficulties in being liberated from the ventilator.”
In terms of medications to facilitate ventilator liberation, benzodiazepines, dexmedetomidine, and propofol all have roles to play, according to Dr. Fraser. Clinicians have to consider agent-specific side effects, pharmacokinetics and dynamics, and “econotoxicity,” or the cost of care, he added.
Although there are few comparative data available to guide choice of medication, Dr. Fraser and his colleagues have published a systematic review and meta-analysis of randomized trials of benzodiazepine versus nonbenzodiazepine-based sedation for mechanically ventilated, critically ill adult patients (Crit Care Med. 2013 Sep;41[9 Suppl 1]:S30-8. doi: 10.1097/CCM.0b013e3182a16898).
They found that dexmedetomidine- or propofol-based sedation regimens appeared to reduce mechanical ventilation duration and length of ICU stay versus benzodiazepine-based sedation, but they stated that larger controlled studies would be needed to further define outcomes in this setting.
More recently, other investigators reported an evaluation of 9,603 consecutive mechanical ventilation episodes (Chest. 2016 Jun;149[6]:1373-9. doi: 10.1378/chest.15-1389). In this large, real-world experience, propofol and dexmedetomidine were both associated with less time to extubation versus benzodiazepines, and dexmedetomidine was associated with less time to extubation versus propofol.
Relatively few patients (about 12%), however, received dexmedetomidine in that large series, and that was mostly in the setting of cardiac surgery, Dr. Fraser noted. Moreover, the investigators reported finding no differences between any two agents in hospital discharge or mortality hazard ratio.
“We’re not suggesting the benzodiazepines as routine sedative agents in our patient populations,” Dr. Fraser said in his presentation. “The primary reason is that they result in a longer time on the vent, typically between 1 and 2 days.”
But this doesn’t mean that the benzodiazepines are the “devil’s handiwork,” he added, noting that they may be useful in patients with anxiety related to ventilator weaning and those recovering from hemodynamic instability or at risk for GABA-agonist withdrawal.
Dexmedetomidine is opioid sparing and has a minimal effect on respiratory drive, among other advantages; however, some potential drawbacks include its hemodynamic effects and its cost, according to Dr. Fraser.
Dr. Fraser said that his institution’s daily acquisition cost for dexmedetomidine is $500, compared with $120 for propofol and $40 for benzodiazepines, but some pharmacoeconomic evaluations suggest use of dexmedetomidine may actually save between $3,000 and $9,000 per ICU admission. “At least in our place, one day in the ICU costs about $5,000, so that all makes sense … and I can argue fairly effectively that dexmedetomidine really isn’t that expensive compared to midazolam,” he said.
Dr. Fraser said that he had no disclosures related to his presentation.
SAN ANTONIO – Among medications to facilitate extubation, dexmedetomidine offers favorable attributes, but whether it’s the best choice for patients who have difficulty being liberated from the ventilator remains to be proven, said Gilles L. Fraser, BS Pharm, PharmD.
The current CHEST/ATS guidelines on liberation from mechanical ventilation in critically ill adults strongly suggest extubation to noninvasive mechanical ventilation in high-risk patients (Chest. 2017 Jan;151[1]:160-5. doi: 10.1016/j.chest.2016.10.037). Guideline authors also suggested protocols attempting to minimize sedation for acutely hospitalized patients ventilated for more than 24 hours, based on some evidence showing a trend toward shorter ventilation time and ICU stay, as well as lower short-term mortality.
, one of the coauthors of the guidelines, during his presentation at the Critical Care Congress sponsored by the Society for Critical Care Medicine.
“I’ll leave you up to your own devices,” he told attendees at a session on conundrums in critical care that are not addressed in current guidelines. “We use it all the time, frankly, but I don’t have any firm data to support that contention.”
Despite best practices, extubation attempts are not always successful: “If you follow the rules of the road, success is going to occur about 85% of the time,” said Dr. Fraser, who is a clinical pharmacist at Maine Medical Center, Portland, and professor of medicine at Tufts University, Boston. “That means that about 15% of our patients have difficulties in being liberated from the ventilator.”
In terms of medications to facilitate ventilator liberation, benzodiazepines, dexmedetomidine, and propofol all have roles to play, according to Dr. Fraser. Clinicians have to consider agent-specific side effects, pharmacokinetics and dynamics, and “econotoxicity,” or the cost of care, he added.
Although there are few comparative data available to guide choice of medication, Dr. Fraser and his colleagues have published a systematic review and meta-analysis of randomized trials of benzodiazepine versus nonbenzodiazepine-based sedation for mechanically ventilated, critically ill adult patients (Crit Care Med. 2013 Sep;41[9 Suppl 1]:S30-8. doi: 10.1097/CCM.0b013e3182a16898).
They found that dexmedetomidine- or propofol-based sedation regimens appeared to reduce mechanical ventilation duration and length of ICU stay versus benzodiazepine-based sedation, but they stated that larger controlled studies would be needed to further define outcomes in this setting.
More recently, other investigators reported an evaluation of 9,603 consecutive mechanical ventilation episodes (Chest. 2016 Jun;149[6]:1373-9. doi: 10.1378/chest.15-1389). In this large, real-world experience, propofol and dexmedetomidine were both associated with less time to extubation versus benzodiazepines, and dexmedetomidine was associated with less time to extubation versus propofol.
Relatively few patients (about 12%), however, received dexmedetomidine in that large series, and that was mostly in the setting of cardiac surgery, Dr. Fraser noted. Moreover, the investigators reported finding no differences between any two agents in hospital discharge or mortality hazard ratio.
“We’re not suggesting the benzodiazepines as routine sedative agents in our patient populations,” Dr. Fraser said in his presentation. “The primary reason is that they result in a longer time on the vent, typically between 1 and 2 days.”
But this doesn’t mean that the benzodiazepines are the “devil’s handiwork,” he added, noting that they may be useful in patients with anxiety related to ventilator weaning and those recovering from hemodynamic instability or at risk for GABA-agonist withdrawal.
Dexmedetomidine is opioid sparing and has a minimal effect on respiratory drive, among other advantages; however, some potential drawbacks include its hemodynamic effects and its cost, according to Dr. Fraser.
Dr. Fraser said that his institution’s daily acquisition cost for dexmedetomidine is $500, compared with $120 for propofol and $40 for benzodiazepines, but some pharmacoeconomic evaluations suggest use of dexmedetomidine may actually save between $3,000 and $9,000 per ICU admission. “At least in our place, one day in the ICU costs about $5,000, so that all makes sense … and I can argue fairly effectively that dexmedetomidine really isn’t that expensive compared to midazolam,” he said.
Dr. Fraser said that he had no disclosures related to his presentation.
SAN ANTONIO – Among medications to facilitate extubation, dexmedetomidine offers favorable attributes, but whether it’s the best choice for patients who have difficulty being liberated from the ventilator remains to be proven, said Gilles L. Fraser, BS Pharm, PharmD.
The current CHEST/ATS guidelines on liberation from mechanical ventilation in critically ill adults strongly suggest extubation to noninvasive mechanical ventilation in high-risk patients (Chest. 2017 Jan;151[1]:160-5. doi: 10.1016/j.chest.2016.10.037). Guideline authors also suggested protocols attempting to minimize sedation for acutely hospitalized patients ventilated for more than 24 hours, based on some evidence showing a trend toward shorter ventilation time and ICU stay, as well as lower short-term mortality.
, one of the coauthors of the guidelines, during his presentation at the Critical Care Congress sponsored by the Society for Critical Care Medicine.
“I’ll leave you up to your own devices,” he told attendees at a session on conundrums in critical care that are not addressed in current guidelines. “We use it all the time, frankly, but I don’t have any firm data to support that contention.”
Despite best practices, extubation attempts are not always successful: “If you follow the rules of the road, success is going to occur about 85% of the time,” said Dr. Fraser, who is a clinical pharmacist at Maine Medical Center, Portland, and professor of medicine at Tufts University, Boston. “That means that about 15% of our patients have difficulties in being liberated from the ventilator.”
In terms of medications to facilitate ventilator liberation, benzodiazepines, dexmedetomidine, and propofol all have roles to play, according to Dr. Fraser. Clinicians have to consider agent-specific side effects, pharmacokinetics and dynamics, and “econotoxicity,” or the cost of care, he added.
Although there are few comparative data available to guide choice of medication, Dr. Fraser and his colleagues have published a systematic review and meta-analysis of randomized trials of benzodiazepine versus nonbenzodiazepine-based sedation for mechanically ventilated, critically ill adult patients (Crit Care Med. 2013 Sep;41[9 Suppl 1]:S30-8. doi: 10.1097/CCM.0b013e3182a16898).
They found that dexmedetomidine- or propofol-based sedation regimens appeared to reduce mechanical ventilation duration and length of ICU stay versus benzodiazepine-based sedation, but they stated that larger controlled studies would be needed to further define outcomes in this setting.
More recently, other investigators reported an evaluation of 9,603 consecutive mechanical ventilation episodes (Chest. 2016 Jun;149[6]:1373-9. doi: 10.1378/chest.15-1389). In this large, real-world experience, propofol and dexmedetomidine were both associated with less time to extubation versus benzodiazepines, and dexmedetomidine was associated with less time to extubation versus propofol.
Relatively few patients (about 12%), however, received dexmedetomidine in that large series, and that was mostly in the setting of cardiac surgery, Dr. Fraser noted. Moreover, the investigators reported finding no differences between any two agents in hospital discharge or mortality hazard ratio.
“We’re not suggesting the benzodiazepines as routine sedative agents in our patient populations,” Dr. Fraser said in his presentation. “The primary reason is that they result in a longer time on the vent, typically between 1 and 2 days.”
But this doesn’t mean that the benzodiazepines are the “devil’s handiwork,” he added, noting that they may be useful in patients with anxiety related to ventilator weaning and those recovering from hemodynamic instability or at risk for GABA-agonist withdrawal.
Dexmedetomidine is opioid sparing and has a minimal effect on respiratory drive, among other advantages; however, some potential drawbacks include its hemodynamic effects and its cost, according to Dr. Fraser.
Dr. Fraser said that his institution’s daily acquisition cost for dexmedetomidine is $500, compared with $120 for propofol and $40 for benzodiazepines, but some pharmacoeconomic evaluations suggest use of dexmedetomidine may actually save between $3,000 and $9,000 per ICU admission. “At least in our place, one day in the ICU costs about $5,000, so that all makes sense … and I can argue fairly effectively that dexmedetomidine really isn’t that expensive compared to midazolam,” he said.
Dr. Fraser said that he had no disclosures related to his presentation.
EXPERT ANALYSIS FROM CCC47
New device cuts postoperative pulmonary complications
SAN ANTONIO – according to results of a nonrandomized study including high-risk patients undergoing elective surgical procedures.
“For certain types of surgical procedures, this therapy (MetaNeb, Hill-Rom) may provide a benefit for high-risk patients in terms of reducing their pulmonary complications and their hospital stay,” said Toan Huynh, MD, lead investigator and director of trauma research at Carolinas HealthCare System, Charlotte, N.C., at the Critical Care Congress sponsored by the Society for Critical Care Medicine.
Currently, aggressive management of high-risk patients with strategies such as optimal analgesia, early ambulation, secretion mobilization, and lung expansion are used to try to reduce the incidence of postoperative pulmonary complications, noted Dr. Huynh, in an interview.
In this study, Dr. Huynh and his colleagues from the University of Pennsylvania, Philadelphia, and the Lahey Hospital & Medical Center, Burlington, Mass., sought to evaluate the efficacy of the MetaNeb system, which delivers continuous high-frequency oscillation, continuous positive expiratory pressure, and in-line aerosol flow in one combined unit. To estimate usual postoperative pulmonary complication rates, they first queried CPT and ICD-9-CM codes to identify a total of 210 patients who had undergone thoracic, upper-abdominal, or aortic open surgical procedures. Then, in the second stage of the study, the investigators prospectively enrolled 209 subjects who underwent those types of surgery with the MetaNeb system in addition to a standard postoperative respiratory regimen. All patients were high risk as defined by having either an American Society of Anesthesiologists classification of at least 3 or an ASA classification of 2 along with one or more comorbidities, such as COPD or recent smoking history.
Among the patients managed with MetaNeb, 33 (15.8%) experienced one or more pulmonary complications, compared with 48 (22.9%) in the retrospective cohort (P = 0.06). For intubated patients, at least one complication was seen in 22 patients (36.7%) in the MetaNeb group, compared with 37 (69.8%) in the comparison group (P less than .05). Time on mechanical ventilation was 8.5 hours in the MetaNeb group versus 23.7 hours in the comparison group (P less than .05).
Use of the device was also associated with decreased length of hospital stay, but the difference between lengths of stay was not statistically significant. Hospital length of stay was 6.8 days in the MetaNeb versus 8.4 days in the comparison groups.“In the current day and age of value-based health care, I think any kind of reduction in expenditure related to health care costs would be compelling for clinicians,” Dr. Huynh said in the interview.
Further study may be needed to better define the role of the combined modality system in clinical practice, according to Dr. Huynh.
“This is sort of a ‘before and after’ nonrandomized trial,” Dr. Huynh explained. “I think, ideally, if we can do a truly controlled, randomized trial, that will be much more powerful.”
The study was sponsored by Hill-Rom, which manufactures the device under study. Dr. Huynh said he and coinvestigators had no financial conflicts related to the research.
SOURCE: Huynh T et al. Critical Care Congress, Abstract 17.
SAN ANTONIO – according to results of a nonrandomized study including high-risk patients undergoing elective surgical procedures.
“For certain types of surgical procedures, this therapy (MetaNeb, Hill-Rom) may provide a benefit for high-risk patients in terms of reducing their pulmonary complications and their hospital stay,” said Toan Huynh, MD, lead investigator and director of trauma research at Carolinas HealthCare System, Charlotte, N.C., at the Critical Care Congress sponsored by the Society for Critical Care Medicine.
Currently, aggressive management of high-risk patients with strategies such as optimal analgesia, early ambulation, secretion mobilization, and lung expansion are used to try to reduce the incidence of postoperative pulmonary complications, noted Dr. Huynh, in an interview.
In this study, Dr. Huynh and his colleagues from the University of Pennsylvania, Philadelphia, and the Lahey Hospital & Medical Center, Burlington, Mass., sought to evaluate the efficacy of the MetaNeb system, which delivers continuous high-frequency oscillation, continuous positive expiratory pressure, and in-line aerosol flow in one combined unit. To estimate usual postoperative pulmonary complication rates, they first queried CPT and ICD-9-CM codes to identify a total of 210 patients who had undergone thoracic, upper-abdominal, or aortic open surgical procedures. Then, in the second stage of the study, the investigators prospectively enrolled 209 subjects who underwent those types of surgery with the MetaNeb system in addition to a standard postoperative respiratory regimen. All patients were high risk as defined by having either an American Society of Anesthesiologists classification of at least 3 or an ASA classification of 2 along with one or more comorbidities, such as COPD or recent smoking history.
Among the patients managed with MetaNeb, 33 (15.8%) experienced one or more pulmonary complications, compared with 48 (22.9%) in the retrospective cohort (P = 0.06). For intubated patients, at least one complication was seen in 22 patients (36.7%) in the MetaNeb group, compared with 37 (69.8%) in the comparison group (P less than .05). Time on mechanical ventilation was 8.5 hours in the MetaNeb group versus 23.7 hours in the comparison group (P less than .05).
Use of the device was also associated with decreased length of hospital stay, but the difference between lengths of stay was not statistically significant. Hospital length of stay was 6.8 days in the MetaNeb versus 8.4 days in the comparison groups.“In the current day and age of value-based health care, I think any kind of reduction in expenditure related to health care costs would be compelling for clinicians,” Dr. Huynh said in the interview.
Further study may be needed to better define the role of the combined modality system in clinical practice, according to Dr. Huynh.
“This is sort of a ‘before and after’ nonrandomized trial,” Dr. Huynh explained. “I think, ideally, if we can do a truly controlled, randomized trial, that will be much more powerful.”
The study was sponsored by Hill-Rom, which manufactures the device under study. Dr. Huynh said he and coinvestigators had no financial conflicts related to the research.
SOURCE: Huynh T et al. Critical Care Congress, Abstract 17.
SAN ANTONIO – according to results of a nonrandomized study including high-risk patients undergoing elective surgical procedures.
“For certain types of surgical procedures, this therapy (MetaNeb, Hill-Rom) may provide a benefit for high-risk patients in terms of reducing their pulmonary complications and their hospital stay,” said Toan Huynh, MD, lead investigator and director of trauma research at Carolinas HealthCare System, Charlotte, N.C., at the Critical Care Congress sponsored by the Society for Critical Care Medicine.
Currently, aggressive management of high-risk patients with strategies such as optimal analgesia, early ambulation, secretion mobilization, and lung expansion are used to try to reduce the incidence of postoperative pulmonary complications, noted Dr. Huynh, in an interview.
In this study, Dr. Huynh and his colleagues from the University of Pennsylvania, Philadelphia, and the Lahey Hospital & Medical Center, Burlington, Mass., sought to evaluate the efficacy of the MetaNeb system, which delivers continuous high-frequency oscillation, continuous positive expiratory pressure, and in-line aerosol flow in one combined unit. To estimate usual postoperative pulmonary complication rates, they first queried CPT and ICD-9-CM codes to identify a total of 210 patients who had undergone thoracic, upper-abdominal, or aortic open surgical procedures. Then, in the second stage of the study, the investigators prospectively enrolled 209 subjects who underwent those types of surgery with the MetaNeb system in addition to a standard postoperative respiratory regimen. All patients were high risk as defined by having either an American Society of Anesthesiologists classification of at least 3 or an ASA classification of 2 along with one or more comorbidities, such as COPD or recent smoking history.
Among the patients managed with MetaNeb, 33 (15.8%) experienced one or more pulmonary complications, compared with 48 (22.9%) in the retrospective cohort (P = 0.06). For intubated patients, at least one complication was seen in 22 patients (36.7%) in the MetaNeb group, compared with 37 (69.8%) in the comparison group (P less than .05). Time on mechanical ventilation was 8.5 hours in the MetaNeb group versus 23.7 hours in the comparison group (P less than .05).
Use of the device was also associated with decreased length of hospital stay, but the difference between lengths of stay was not statistically significant. Hospital length of stay was 6.8 days in the MetaNeb versus 8.4 days in the comparison groups.“In the current day and age of value-based health care, I think any kind of reduction in expenditure related to health care costs would be compelling for clinicians,” Dr. Huynh said in the interview.
Further study may be needed to better define the role of the combined modality system in clinical practice, according to Dr. Huynh.
“This is sort of a ‘before and after’ nonrandomized trial,” Dr. Huynh explained. “I think, ideally, if we can do a truly controlled, randomized trial, that will be much more powerful.”
The study was sponsored by Hill-Rom, which manufactures the device under study. Dr. Huynh said he and coinvestigators had no financial conflicts related to the research.
SOURCE: Huynh T et al. Critical Care Congress, Abstract 17.
AT THE CRITICAL CARE CONGRESS
Key clinical point: A device that combines lung expansion, secretion clearance, and aerosol delivery (MetaNeb) appears to reduce postoperative pulmonary complications and resource use.Major finding: Pulmonary complications occurred in 36.7% of intubated patients, compared with 69.8% for a prospectively evaluated reference population (P less than 0.05).
Data source: A prospective, nonrandomized, two-stage study including 417 subjects who underwent thoracic, upper-abdominal, or aortic open surgical procedure at one of three centers.
Disclosures: The study was sponsored by Hill-Rom, which manufactures the MetaNeb device. Investigators had no financial conflicts related to the study.
Source: Huynh T et al. Critical Care Congress, Abstract 17.