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Protocol-based resuscitation did not reduce sepsis deaths or morbidity, compared with usual care, in the Protocolized Care for Early Septic Shock study conducted at 31 U.S. academic hospitals.
Among 1,341 evaluable patients, the primary endpoint of 60-day in-hospital mortality was 21% with protocol-based early goal-directed therapy (EGDT), 18.2% with protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions, and 18.9% with usual care according to the treating physician’s judgment.
The difference was not statistically significant between the protocol-based interventions and usual care (relative risk, 1.04; P = .83) or between protocol-based EGDT and protocol-based standard therapy (RR, 1.15; P = .31), according to data presented at the International Symposium on Intensive Care and Emergency Medicine and simultaneously published in the New England Journal of Medicine (N. Engl. J. Med. 2014 March 18 [doi:10.1056/NEJMoa1401602]).
The three groups also did not differ significantly with regard to 90-day mortality, incidence of cardiovascular or respiratory failure, length of hospital stay, or discharge disposition.
The results from ProCESS differ from those reported more than a decade ago in the pivotal, single-center Rivers et al. study, in which mortality was significantly reduced for patients with severe sepsis or septic shock treated with 6 hours of EGDT therapy versus standard therapy (N. Engl. J. Med. 2001;345:1368-77).
Though both trials used the same EGDT protocol delivered by a trained, dedicated team at each site, possible reasons for the discordance are that the Rivers study showed nearly perfect adherence to protocol and that its cohort was slightly older, had higher rates of preexisting heart and liver disease, and had a higher initial serum lactate level, noted Dr. Derek Angus, ProCESS principal investigator and chair of critical care medicine at the University of Pittsburgh.
In addition, changes in the management of critically ill patient in the ensuing decade, including use of lower hemoglobin levels as a threshold for transfusion, use of lung-protection strategies, and tighter blood sugar control, "may have helped lower the overall mortality and may have reduced the marginal benefit of alternative resuscitation strategies," he observed.
Dr. Angus received grant support from the National Institutes of General Medical Sciences and nonfinancial support from Edwards Inc. during the trial, grant support to his university from Eisai, and personal fees from Pfizer and MedImmune outside this trial.
"The critical role of the clinician in the early recognition of
sepsis continues to this day to be fundamental to our efforts to improve
the rate of survival," said pulmonologist Dr. Craig M. Lilly of the University of Massachusetts Memorial Medical Center, Boston. (N. Engl. J. Med. 2014 March 18 [doi:10.1056/NEJMe1402564]). He
cautioned, however, on using the findings to come to the "dubious
conclusion that protocols and decision prompts do not have a role in the
treatment of septic shock."
An important contribution of ProCESS
is the evidence it provides on the early recognition of, and antibiotic
treatment for, sepsis in improving survival, Dr. Lilly observed. Shock
was recognized early in most patients (randomization occurred at an
average of 3 hours after ED arrival), 76% received antimicrobial agents
by randomization, and 97% received IV antimicrobials 6 hours after
randomization.
ProCESS also provides "transformative insights
about the treatments for septic shock that bring generalizable benefits"
when septic shock is recognized in the first hours after ED arrival, he
stated. Notably, that use of central hemodynamic and oxygen-saturation
monitoring in the protocol-based EGDT group did not result in better
outcomes than those achieved with clinical assessment of the adequacy of
circulation.
"State legislation and clinical guidelines,
including those endorsed by the National Quality Forum, should be
updated to remove the requirement for central hemodynamic monitoring and
to focus on less costly, lower-risk, and equally effective
alternatives," Dr. Lilly wrote. Dr. Lilly reported no conflicts.
"The critical role of the clinician in the early recognition of
sepsis continues to this day to be fundamental to our efforts to improve
the rate of survival," said pulmonologist Dr. Craig M. Lilly of the University of Massachusetts Memorial Medical Center, Boston. (N. Engl. J. Med. 2014 March 18 [doi:10.1056/NEJMe1402564]). He
cautioned, however, on using the findings to come to the "dubious
conclusion that protocols and decision prompts do not have a role in the
treatment of septic shock."
An important contribution of ProCESS
is the evidence it provides on the early recognition of, and antibiotic
treatment for, sepsis in improving survival, Dr. Lilly observed. Shock
was recognized early in most patients (randomization occurred at an
average of 3 hours after ED arrival), 76% received antimicrobial agents
by randomization, and 97% received IV antimicrobials 6 hours after
randomization.
ProCESS also provides "transformative insights
about the treatments for septic shock that bring generalizable benefits"
when septic shock is recognized in the first hours after ED arrival, he
stated. Notably, that use of central hemodynamic and oxygen-saturation
monitoring in the protocol-based EGDT group did not result in better
outcomes than those achieved with clinical assessment of the adequacy of
circulation.
"State legislation and clinical guidelines,
including those endorsed by the National Quality Forum, should be
updated to remove the requirement for central hemodynamic monitoring and
to focus on less costly, lower-risk, and equally effective
alternatives," Dr. Lilly wrote. Dr. Lilly reported no conflicts.
"The critical role of the clinician in the early recognition of
sepsis continues to this day to be fundamental to our efforts to improve
the rate of survival," said pulmonologist Dr. Craig M. Lilly of the University of Massachusetts Memorial Medical Center, Boston. (N. Engl. J. Med. 2014 March 18 [doi:10.1056/NEJMe1402564]). He
cautioned, however, on using the findings to come to the "dubious
conclusion that protocols and decision prompts do not have a role in the
treatment of septic shock."
An important contribution of ProCESS
is the evidence it provides on the early recognition of, and antibiotic
treatment for, sepsis in improving survival, Dr. Lilly observed. Shock
was recognized early in most patients (randomization occurred at an
average of 3 hours after ED arrival), 76% received antimicrobial agents
by randomization, and 97% received IV antimicrobials 6 hours after
randomization.
ProCESS also provides "transformative insights
about the treatments for septic shock that bring generalizable benefits"
when septic shock is recognized in the first hours after ED arrival, he
stated. Notably, that use of central hemodynamic and oxygen-saturation
monitoring in the protocol-based EGDT group did not result in better
outcomes than those achieved with clinical assessment of the adequacy of
circulation.
"State legislation and clinical guidelines,
including those endorsed by the National Quality Forum, should be
updated to remove the requirement for central hemodynamic monitoring and
to focus on less costly, lower-risk, and equally effective
alternatives," Dr. Lilly wrote. Dr. Lilly reported no conflicts.
Protocol-based resuscitation did not reduce sepsis deaths or morbidity, compared with usual care, in the Protocolized Care for Early Septic Shock study conducted at 31 U.S. academic hospitals.
Among 1,341 evaluable patients, the primary endpoint of 60-day in-hospital mortality was 21% with protocol-based early goal-directed therapy (EGDT), 18.2% with protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions, and 18.9% with usual care according to the treating physician’s judgment.
The difference was not statistically significant between the protocol-based interventions and usual care (relative risk, 1.04; P = .83) or between protocol-based EGDT and protocol-based standard therapy (RR, 1.15; P = .31), according to data presented at the International Symposium on Intensive Care and Emergency Medicine and simultaneously published in the New England Journal of Medicine (N. Engl. J. Med. 2014 March 18 [doi:10.1056/NEJMoa1401602]).
The three groups also did not differ significantly with regard to 90-day mortality, incidence of cardiovascular or respiratory failure, length of hospital stay, or discharge disposition.
The results from ProCESS differ from those reported more than a decade ago in the pivotal, single-center Rivers et al. study, in which mortality was significantly reduced for patients with severe sepsis or septic shock treated with 6 hours of EGDT therapy versus standard therapy (N. Engl. J. Med. 2001;345:1368-77).
Though both trials used the same EGDT protocol delivered by a trained, dedicated team at each site, possible reasons for the discordance are that the Rivers study showed nearly perfect adherence to protocol and that its cohort was slightly older, had higher rates of preexisting heart and liver disease, and had a higher initial serum lactate level, noted Dr. Derek Angus, ProCESS principal investigator and chair of critical care medicine at the University of Pittsburgh.
In addition, changes in the management of critically ill patient in the ensuing decade, including use of lower hemoglobin levels as a threshold for transfusion, use of lung-protection strategies, and tighter blood sugar control, "may have helped lower the overall mortality and may have reduced the marginal benefit of alternative resuscitation strategies," he observed.
Dr. Angus received grant support from the National Institutes of General Medical Sciences and nonfinancial support from Edwards Inc. during the trial, grant support to his university from Eisai, and personal fees from Pfizer and MedImmune outside this trial.
Protocol-based resuscitation did not reduce sepsis deaths or morbidity, compared with usual care, in the Protocolized Care for Early Septic Shock study conducted at 31 U.S. academic hospitals.
Among 1,341 evaluable patients, the primary endpoint of 60-day in-hospital mortality was 21% with protocol-based early goal-directed therapy (EGDT), 18.2% with protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions, and 18.9% with usual care according to the treating physician’s judgment.
The difference was not statistically significant between the protocol-based interventions and usual care (relative risk, 1.04; P = .83) or between protocol-based EGDT and protocol-based standard therapy (RR, 1.15; P = .31), according to data presented at the International Symposium on Intensive Care and Emergency Medicine and simultaneously published in the New England Journal of Medicine (N. Engl. J. Med. 2014 March 18 [doi:10.1056/NEJMoa1401602]).
The three groups also did not differ significantly with regard to 90-day mortality, incidence of cardiovascular or respiratory failure, length of hospital stay, or discharge disposition.
The results from ProCESS differ from those reported more than a decade ago in the pivotal, single-center Rivers et al. study, in which mortality was significantly reduced for patients with severe sepsis or septic shock treated with 6 hours of EGDT therapy versus standard therapy (N. Engl. J. Med. 2001;345:1368-77).
Though both trials used the same EGDT protocol delivered by a trained, dedicated team at each site, possible reasons for the discordance are that the Rivers study showed nearly perfect adherence to protocol and that its cohort was slightly older, had higher rates of preexisting heart and liver disease, and had a higher initial serum lactate level, noted Dr. Derek Angus, ProCESS principal investigator and chair of critical care medicine at the University of Pittsburgh.
In addition, changes in the management of critically ill patient in the ensuing decade, including use of lower hemoglobin levels as a threshold for transfusion, use of lung-protection strategies, and tighter blood sugar control, "may have helped lower the overall mortality and may have reduced the marginal benefit of alternative resuscitation strategies," he observed.
Dr. Angus received grant support from the National Institutes of General Medical Sciences and nonfinancial support from Edwards Inc. during the trial, grant support to his university from Eisai, and personal fees from Pfizer and MedImmune outside this trial.
FROM ISICEM 2014
Major finding: Sixty-day mortality was 21% with protocol-based EGDT, 18.2% with protocol-based standard therapy, and 18.9% with usual care.
Data source: A prospective study of 1,341 patients with septic shock.
Disclosures: Dr. Angus received grant support from the National Institutes of General Medical Sciences and nonfinancial support from Edwards Inc. during the trial, grant support to his university from Eisai, and personal fees from Pfizer and MedImmune outside this trial.