A Randomized Trial of Protocol-Based Care for Early Septic Shock

In septic shock, the first few hours of care are critical for survival. In this study, two protocols for the care of patients with septic shock were compared with usual care with respect to 60-day mortality and other outcomes. There were no significant differences in outcome. There are more than 750...

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Vydáno v:The New England journal of medicine Ročník 370; číslo 18; s. 1683 - 1693
Hlavní autoři: YEALY, Donald M, KELLUM, John A, FILBIN, Michael R, SHAPIRO, Nathan I, ANGUS, Derek C, HUANG, David T, BARNATO, Amber E, WEISSFELD, Lisa A, PIKE, Francis, TERNDRUP, Thomas, WANG, Henry E, HOU, Peter C, LOVECCHIO, Frank
Médium: Journal Article
Jazyk:angličtina
Vydáno: Waltham, MA Massachusetts Medical Society 01.05.2014
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ISSN:0028-4793, 1533-4406, 1533-4406
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Abstract In septic shock, the first few hours of care are critical for survival. In this study, two protocols for the care of patients with septic shock were compared with usual care with respect to 60-day mortality and other outcomes. There were no significant differences in outcome. There are more than 750,000 cases of severe sepsis and septic shock in the United States each year. 1 Most patients who present with sepsis receive initial care in the emergency department, and the short-term mortality is 20% or more. 2 , 3 In 2001, Rivers et al. reported that among patients with severe sepsis or septic shock in a single urban emergency department, mortality was significantly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT) than among those who were given standard therapy (30.5% vs. 46.5%). 4 On the basis of the premise that usual care . . .
AbstractList In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary.BACKGROUNDIn a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary.In 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support.METHODSIn 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support.We enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support.RESULTSWe enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support.In a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. (Funded by the National Institute of General Medical Sciences; ProCESS ClinicalTrials.gov number, NCT00510835.).CONCLUSIONSIn a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. (Funded by the National Institute of General Medical Sciences; ProCESS ClinicalTrials.gov number, NCT00510835.).
BackgroundIn a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary.MethodsIn 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support.ResultsWe enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support.ConclusionsIn a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. (Funded by the National Institute of General Medical Sciences; ProCESS ClinicalTrials.gov number, NCT00510835.)
In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary. In 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support. We enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support. In a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. (Funded by the National Institute of General Medical Sciences; ProCESS ClinicalTrials.gov number, NCT00510835.).
In septic shock, the first few hours of care are critical for survival. In this study, two protocols for the care of patients with septic shock were compared with usual care with respect to 60-day mortality and other outcomes. There were no significant differences in outcome. There are more than 750,000 cases of severe sepsis and septic shock in the United States each year. 1 Most patients who present with sepsis receive initial care in the emergency department, and the short-term mortality is 20% or more. 2 , 3 In 2001, Rivers et al. reported that among patients with severe sepsis or septic shock in a single urban emergency department, mortality was significantly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT) than among those who were given standard therapy (30.5% vs. 46.5%). 4 On the basis of the premise that usual care . . .
Author KELLUM, John A
TERNDRUP, Thomas
SHAPIRO, Nathan I
FILBIN, Michael R
WEISSFELD, Lisa A
ANGUS, Derek C
WANG, Henry E
LOVECCHIO, Frank
HUANG, David T
PIKE, Francis
BARNATO, Amber E
YEALY, Donald M
HOU, Peter C
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  givenname: Donald M
  surname: YEALY
  fullname: YEALY, Donald M
  organization: University of Pittsburgh, Pittsburgh, United States
– sequence: 2
  givenname: John A
  surname: KELLUM
  fullname: KELLUM, John A
  organization: University of Pittsburgh, Pittsburgh, United States
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  givenname: Michael R
  surname: FILBIN
  fullname: FILBIN, Michael R
  organization: Massachusetts General Hospital, Boston, United States
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  givenname: Nathan I
  surname: SHAPIRO
  fullname: SHAPIRO, Nathan I
  organization: Beth Israel Deaconess Medical Center, Boston, United States
– sequence: 5
  givenname: Derek C
  surname: ANGUS
  fullname: ANGUS, Derek C
  organization: University of Pittsburgh, Pittsburgh, United States
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  givenname: David T
  surname: HUANG
  fullname: HUANG, David T
  organization: University of Pittsburgh, Pittsburgh, United States
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  givenname: Amber E
  surname: BARNATO
  fullname: BARNATO, Amber E
  organization: University of Pittsburgh, Pittsburgh, United States
– sequence: 8
  givenname: Lisa A
  surname: WEISSFELD
  fullname: WEISSFELD, Lisa A
  organization: University of Pittsburgh, Pittsburgh, United States
– sequence: 9
  givenname: Francis
  surname: PIKE
  fullname: PIKE, Francis
  organization: University of Pittsburgh, Pittsburgh, United States
– sequence: 10
  givenname: Thomas
  surname: TERNDRUP
  fullname: TERNDRUP, Thomas
  organization: Ohio State University, Columbus, United States
– sequence: 11
  givenname: Henry E
  surname: WANG
  fullname: WANG, Henry E
  organization: University of Alabama at Birmingham, Birmingham, United States
– sequence: 12
  givenname: Peter C
  surname: HOU
  fullname: HOU, Peter C
  organization: Brigham and Women's Hospital, Boston, United States
– sequence: 13
  givenname: Frank
  surname: LOVECCHIO
  fullname: LOVECCHIO, Frank
  organization: Maricopa Medical Center, Phoenix, United States
BackLink http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28361396$$DView record in Pascal Francis
https://www.ncbi.nlm.nih.gov/pubmed/24635773$$D View this record in MEDLINE/PubMed
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Conrad, Steven A
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Wang, Henry E
Fine, Jonathan
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McCurdy, Michael T
Huang, David T
Berry, Donald A
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Ellender, Timothy J
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Rittenberger, Jon S
Gimbel, Elizabeth
Swadron, Stuart
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Pearl, Ronald G
Weinert, Craig
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Brock, Daniel W
Kellum, John A
LoVecchio, Frank
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Limkakeng, Jr, Alexander T
Hou, Peter C
Wilber, Scott T
Dubinski, Diane
Cnaan, Avital
Fost, Norman C
Mainhart, Allison
Delbridge, Theodore R
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Watts, Hannah
Nathens, Avery B
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2015 INIST-CNRS
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Issue 18
Keywords Infection
Medicine
Septic shock
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A complete list of investigators in the Protocolized Care for Early Septic Shock (ProCESS) study is provided in the Supplementary Appendix, available at NEJM.org
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SSID ssj0000149
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Snippet In septic shock, the first few hours of care are critical for survival. In this study, two protocols for the care of patients with septic shock were compared...
In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock,...
BackgroundIn a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic...
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StartPage 1683
SubjectTerms Adult
Aged
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Anti-Bacterial Agents - therapeutic use
Biological and medical sciences
Blood Transfusion
Cardiotonic Agents - therapeutic use
Clinical Protocols
Clinical trials
Combined Modality Therapy
Emergency and intensive care: infection, septic shock
Emergency Service, Hospital
Evidence-based medicine
Female
Fluid Therapy
General aspects
Hospital Mortality
Humans
Intensive care medicine
Intravenous administration
Male
Medical sciences
Medical treatment
Middle Aged
Mortality
Outcome Assessment (Health Care)
Protocol
Resuscitation - standards
Sepsis
Septic shock
Shock, Septic - diagnosis
Shock, Septic - mortality
Shock, Septic - therapy
Vasoconstrictor Agents - therapeutic use
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Title A Randomized Trial of Protocol-Based Care for Early Septic Shock
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