Request to Join
has invited you to join this group
has invited you to join this group
Director, Intensive Care National Audit & Research Centre
Professor of Health Economics Methodology, London School of Hygiene and Tropical Medicine
Washington University; Emergency Medicine and Surgical / Trauma Critical Care
Head Statistician, Intensive Care National Audit & Research Centre
Chair, Trauma Audit and Research Network (TARN)
Director of Research, Department of Emergency Medicine, University of Mississippi Medical Center
Instructor, Pulmonary and Critical Care Medicine, Brigham and Women's Hospital
Assistant Program Director, Pulmonary, Critical Care and Sleep Medicine, NYU School of Medicine
Pulmonary Attending Physician, New York Presbyterian Hospital
Chair, Dept of Emergency Medicine, UMMC
Medical Director, Harborview Sepsis Program
Medical Director, Pulmonary Ward, Wayne State University School of Medicine
Program Director, Pulmonary & Critical Care, U Maryland
Associate Professor, Uniformed Services University of the Health Sciences
Society of Critical Care Medicine's Sepsis 3rd World Task Force Member
Principal Investigator, ProACT
Professor and Chair of Emergency Medicine, University of Pittsburgh
Director, Oncology and Bone Marrow Transplant Critical Care, Johns Hopkins Hospital
Fellowship Program Director, Pulmonary and Critical Care Medicine, Cedars-Sinai Medical Center
Intensivist and Immunologist at the University of Chicago
Pulmonary and Critical Care Fellow, U Chicago
MD/PhD candidate at the University of Mississippi Medical Center
Pulmonary and Critical Care Medicine Physician
General Internist, Massachusetts General Hospital, Research Fellow, Brigham and Women's Hospital
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.
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.
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%.
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.)
Director, Intensive Care National Audit & Research Centre
Professor of Health Economics Methodology, London School of Hygiene and Tropical Medicine
Washington University; Emergency Medicine and Surgical / Trauma Critical Care
Head Statistician, Intensive Care National Audit & Research Centre
Chair, Trauma Audit and Research Network (TARN)
Director of Research, Department of Emergency Medicine, University of Mississippi Medical Center
Instructor, Pulmonary and Critical Care Medicine, Brigham and Women's Hospital
Assistant Program Director, Pulmonary, Critical Care and Sleep Medicine, NYU School of Medicine
Pulmonary Attending Physician, New York Presbyterian Hospital
Chair, Dept of Emergency Medicine, UMMC
Medical Director, Harborview Sepsis Program
Medical Director, Pulmonary Ward, Wayne State University School of Medicine
Program Director, Pulmonary & Critical Care, U Maryland
Associate Professor, Uniformed Services University of the Health Sciences
Society of Critical Care Medicine's Sepsis 3rd World Task Force Member
Principal Investigator, ProACT
Professor and Chair of Emergency Medicine, University of Pittsburgh
Director, Oncology and Bone Marrow Transplant Critical Care, Johns Hopkins Hospital
Fellowship Program Director, Pulmonary and Critical Care Medicine, Cedars-Sinai Medical Center
Intensivist and Immunologist at the University of Chicago
Pulmonary and Critical Care Fellow, U Chicago
MD/PhD candidate at the University of Mississippi Medical Center
Pulmonary and Critical Care Medicine Physician
General Internist, Massachusetts General Hospital, Research Fellow, Brigham and Women's Hospital