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Authors
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Director, Intensive Care National Audit & Research CentreKathryn Rowan, PhD
Director, Intensive Care National Audit & Research CentreDirector, Intensive Care National Audit & Research Centre
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Professor of Health Economics Methodology, London School of Hygiene and Tropical MedicineRichard Grieve, MSc, PhD
Professor of Health Economics Methodology, London School of Hygiene and Tropical MedicineProfessor of Health Economics Methodology, London School of Hygiene and Tropical Medicine
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Washington University; Emergency Medicine and Surgical / Trauma Critical CareTiffany Osborn, MD, MPH
Washington University; Emergency Medicine and Surgical / Trauma Critical CareWashington University; Emergency Medicine and Surgical / Trauma Critical Care
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Head Statistician, Intensive Care National Audit & Research CentreDavid Harrison, PhD
Head Statistician, Intensive Care National Audit & Research CentreHead Statistician, Intensive Care National Audit & Research Centre
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Chair, Trauma Audit and Research Network (TARN)Timothy Coats, MD
Chair, Trauma Audit and Research Network (TARN)Chair, Trauma Audit and Research Network (TARN)
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Experts
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Director of Research, Department of Emergency Medicine, University of Mississippi Medical CenterMichael Puskarich, MD
Director of Research, Department of Emergency Medicine, University of Mississippi Medical CenterDirector of Research, Department of Emergency Medicine, University of Mississippi Medical Center
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Instructor, Pulmonary and Critical Care Medicine, Brigham and Women's HospitalEdy Kim, MD PhD
Instructor, Pulmonary and Critical Care Medicine, Brigham and Women's HospitalInstructor, Pulmonary and Critical Care Medicine, Brigham and Women's Hospital
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Assistant Program Director, Pulmonary, Critical Care and Sleep Medicine, NYU School of MedicineAshwin Basavaraj, MD
Assistant Program Director, Pulmonary, Critical Care and Sleep Medicine, NYU School of MedicineAssistant Program Director, Pulmonary, Critical Care and Sleep Medicine, NYU School of Medicine
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Pulmonary Attending Physician, New York Presbyterian HospitalEdward Schenck, MD
Pulmonary Attending Physician, New York Presbyterian HospitalPulmonary Attending Physician, New York Presbyterian Hospital
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Chair, Dept of Emergency Medicine, UMMCAlan Jones, MD, FACEP
Chair, Dept of Emergency Medicine, UMMCChair, Dept of Emergency Medicine, UMMC
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Medical Director, Harborview Sepsis ProgramDavid Carlbom, MD
Medical Director, Harborview Sepsis ProgramMedical Director, Harborview Sepsis Program
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Medical Director, Pulmonary Ward, Wayne State University School of MedicineDaniel Ouellette, MD
Medical Director, Pulmonary Ward, Wayne State University School of MedicineMedical Director, Pulmonary Ward, Wayne State University School of Medicine
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Program Director, Pulmonary & Critical Care, U MarylandNirav Shah, MD, FCCP
Program Director, Pulmonary & Critical Care, U MarylandProgram Director, Pulmonary & Critical Care, U Maryland
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Associate Professor, Uniformed Services University of the Health SciencesAlexander Niven, MD
Associate Professor, Uniformed Services University of the Health SciencesAssociate Professor, Uniformed Services University of the Health Sciences
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Society of Critical Care Medicine's Sepsis 3rd World Task Force MemberAlfred Papali, MD, CM
Society of Critical Care Medicine's Sepsis 3rd World Task Force MemberSociety of Critical Care Medicine's Sepsis 3rd World Task Force Member
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Principal Investigator, ProACTDavid Huang, MD, MPH
Principal Investigator, ProACTPrincipal Investigator, ProACT
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Professor and Chair of Emergency Medicine, University of PittsburghDonald Yealy, MD
Professor and Chair of Emergency Medicine, University of PittsburghProfessor and Chair of Emergency Medicine, University of Pittsburgh
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Director, Oncology and Bone Marrow Transplant Critical Care, Johns Hopkins HospitalScott Stephens, MD
Director, Oncology and Bone Marrow Transplant Critical Care, Johns Hopkins HospitalDirector, Oncology and Bone Marrow Transplant Critical Care, Johns Hopkins Hospital
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Fellowship Program Director, Pulmonary and Critical Care Medicine, Cedars-Sinai Medical CenterJeremy Falk, MD
Fellowship Program Director, Pulmonary and Critical Care Medicine, Cedars-Sinai Medical CenterFellowship Program Director, Pulmonary and Critical Care Medicine, Cedars-Sinai Medical Center
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Intensivist and Immunologist at the University of ChicagoPhilip Verhoef, MD PhD
Intensivist and Immunologist at the University of ChicagoIntensivist and Immunologist at the University of Chicago
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Pulmonary and Critical Care Fellow, U ChicagoBhakti Patel, MD
Pulmonary and Critical Care Fellow, U ChicagoPulmonary and Critical Care Fellow, U Chicago
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Moderators
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MD/PhD candidate at the University of Mississippi Medical CenterPeter Mittwede
MD/PhD candidate at the University of Mississippi Medical CenterMD/PhD candidate at the University of Mississippi Medical Center
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Pulmonary and Critical Care Medicine PhysicianNeeti Kanodra, MBBS
Pulmonary and Critical Care Medicine PhysicianPulmonary and Critical Care Medicine Physician
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General Internist, Massachusetts General Hospital, Research Fellow, Brigham and Women's HospitalChana Sacks, MD
General Internist, Massachusetts General Hospital, Research Fellow, Brigham and Women's HospitalGeneral Internist, Massachusetts General Hospital, Research Fellow, Brigham and Women's Hospital
About the Discussion
@NEJM Ask the Authors & Experts: Trial of Early, Goal-Directed Resuscitation for Septic Shock
Original Article
Trial of Early, Goal-Directed Resuscitation for Septic Shock
Background
Early, goal-directed therapy (EGDT) is recommended in international guidelines for the resuscitation of patients presenting with early septic shock. However, adoption has been limited, and uncertainty about its effectiveness remains.
Methods
We conducted a pragmatic randomized trial with an integrated cost-effectiveness analysis in 56 hospitals in England. Patients were randomly assigned to receive either EGDT (a 6-hour resuscitation protocol) or usual care. The primary clinical outcome was all-cause mortality at 90 days.
Results
We enrolled 1260 patients, with 630 assigned to EGDT and 630 to usual care. By 90 days, 184 of 623 patients (29.5%) in the EGDT group and 181 of 620 patients (29.2%) in the usual-care group had died (relative risk in the EGDT group, 1.01; 95% confidence interval [CI], 0.85 to 1.20; P=0.90), for an absolute risk reduction in the EGDT group of −0.3 percentage points (95% CI, −5.4 to 4.7). Increased treatment intensity in the EGDT group was indicated by increased use of intravenous fluids, vasoactive drugs, and red-cell transfusions and reflected by significantly worse organ-failure scores, more days receiving advanced cardiovascular support, and longer stays in the intensive care unit. There were no significant differences in any other secondary outcomes, including health-related quality of life, or in rates of serious adverse events. On average, EGDT increased costs, and the probability that it was cost-effective was below 20%.
Conclusions
In patients with septic shock who were identified early and received intravenous antibiotics and adequate fluid resuscitation, hemodynamic management according to a strict EGDT protocol did not lead to an improvement in outcome. (Funded by the United Kingdom National Institute for Health Research Health Technology Assessment Programme; ProMISe Current Controlled Trials number, ISRCTN36307479.)
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Authors
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Director, Intensive Care National Audit & Research CentreKathryn Rowan, PhD
Director, Intensive Care National Audit & Research Centre
Director, Intensive Care National Audit & Research Centre
-
Professor of Health Economics Methodology, London School of Hygiene and Tropical MedicineRichard Grieve, MSc, PhD
Professor of Health Economics Methodology, London School of Hygiene and Tropical Medicine
Professor of Health Economics Methodology, London School of Hygiene and Tropical Medicine
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Washington University; Emergency Medicine and Surgical / Trauma Critical CareTiffany Osborn, MD, MPH
Washington University; Emergency Medicine and Surgical / Trauma Critical Care
Washington University; Emergency Medicine and Surgical / Trauma Critical Care
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Head Statistician, Intensive Care National Audit & Research CentreDavid Harrison, PhD
Head Statistician, Intensive Care National Audit & Research Centre
Head Statistician, Intensive Care National Audit & Research Centre
-
Chair, Trauma Audit and Research Network (TARN)Timothy Coats, MD
Chair, Trauma Audit and Research Network (TARN)
Chair, Trauma Audit and Research Network (TARN)
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Experts
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Director of Research, Department of Emergency Medicine, University of Mississippi Medical CenterMichael Puskarich, MD
Director of Research, Department of Emergency Medicine, University of Mississippi Medical Center
Director of Research, Department of Emergency Medicine, University of Mississippi Medical Center
-
Instructor, Pulmonary and Critical Care Medicine, Brigham and Women's HospitalEdy Kim, MD PhD
Instructor, Pulmonary and Critical Care Medicine, Brigham and Women's Hospital
Instructor, Pulmonary and Critical Care Medicine, Brigham and Women's Hospital
-
Assistant Program Director, Pulmonary, Critical Care and Sleep Medicine, NYU School of MedicineAshwin Basavaraj, MD
Assistant Program Director, Pulmonary, Critical Care and Sleep Medicine, NYU School of Medicine
Assistant Program Director, Pulmonary, Critical Care and Sleep Medicine, NYU School of Medicine
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Pulmonary Attending Physician, New York Presbyterian HospitalEdward Schenck, MD
Pulmonary Attending Physician, New York Presbyterian Hospital
Pulmonary Attending Physician, New York Presbyterian Hospital
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Chair, Dept of Emergency Medicine, UMMCAlan Jones, MD, FACEP
Chair, Dept of Emergency Medicine, UMMC
Chair, Dept of Emergency Medicine, UMMC
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Medical Director, Harborview Sepsis ProgramDavid Carlbom, MD
Medical Director, Harborview Sepsis Program
Medical Director, Harborview Sepsis Program
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Medical Director, Pulmonary Ward, Wayne State University School of MedicineDaniel Ouellette, MD
Medical Director, Pulmonary Ward, Wayne State University School of Medicine
Medical Director, Pulmonary Ward, Wayne State University School of Medicine
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Program Director, Pulmonary & Critical Care, U MarylandNirav Shah, MD, FCCP
Program Director, Pulmonary & Critical Care, U Maryland
Program Director, Pulmonary & Critical Care, U Maryland
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Associate Professor, Uniformed Services University of the Health SciencesAlexander Niven, MD
Associate Professor, Uniformed Services University of the Health Sciences
Associate Professor, Uniformed Services University of the Health Sciences
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Society of Critical Care Medicine's Sepsis 3rd World Task Force MemberAlfred Papali, MD, CM
Society of Critical Care Medicine's Sepsis 3rd World Task Force Member
Society of Critical Care Medicine's Sepsis 3rd World Task Force Member
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Principal Investigator, ProACTDavid Huang, MD, MPH
Principal Investigator, ProACT
Principal Investigator, ProACT
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Professor and Chair of Emergency Medicine, University of PittsburghDonald Yealy, MD
Professor and Chair of Emergency Medicine, University of Pittsburgh
Professor and Chair of Emergency Medicine, University of Pittsburgh
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Director, Oncology and Bone Marrow Transplant Critical Care, Johns Hopkins HospitalScott Stephens, MD
Director, Oncology and Bone Marrow Transplant Critical Care, Johns Hopkins Hospital
Director, Oncology and Bone Marrow Transplant Critical Care, Johns Hopkins Hospital
-
Fellowship Program Director, Pulmonary and Critical Care Medicine, Cedars-Sinai Medical CenterJeremy Falk, MD
Fellowship Program Director, Pulmonary and Critical Care Medicine, Cedars-Sinai Medical Center
Fellowship Program Director, Pulmonary and Critical Care Medicine, Cedars-Sinai Medical Center
-
Intensivist and Immunologist at the University of ChicagoPhilip Verhoef, MD PhD
Intensivist and Immunologist at the University of Chicago
Intensivist and Immunologist at the University of Chicago
-
Pulmonary and Critical Care Fellow, U ChicagoBhakti Patel, MD
Pulmonary and Critical Care Fellow, U Chicago
Pulmonary and Critical Care Fellow, U Chicago
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Moderators
-
MD/PhD candidate at the University of Mississippi Medical CenterPeter Mittwede
MD/PhD candidate at the University of Mississippi Medical Center
MD/PhD candidate at the University of Mississippi Medical Center
-
Pulmonary and Critical Care Medicine PhysicianNeeti Kanodra, MBBS
Pulmonary and Critical Care Medicine Physician
Pulmonary and Critical Care Medicine Physician
-
General Internist, Massachusetts General Hospital, Research Fellow, Brigham and Women's HospitalChana Sacks, MD
General Internist, Massachusetts General Hospital, Research Fellow, Brigham and Women's Hospital
General Internist, Massachusetts General Hospital, Research Fellow, Brigham and Women's Hospital
