February 3, 2009 (Nashville, Tennessee) — At a late-breaking clinical trials session here at the Society of Critical Care Medicine 38th Critical Care Congress, the phase 3 results of the Surviving Sepsis Campaign were announced.
Principal investigator Mitchell M. Levy, MD, FCCP, FCCM, professor of medicine at Brown University and director of the MICU at Rhode Island Hospital, in Providence, told conference attendees that management "bundles," or protocols, get guideline updates into clinical practice faster and, as a result, reduce the absolute risk for mortality by 7%.
The Surviving Sepsis Campaign was a 2-year trial involving 18 countries, 166 sites, and 15,022 patient charts.
The investigators analyzed the effect of a sepsis resuscitation bundle and a sepsis management bundle on the bedside management of sepsis and the implementation of guideline updates and, as a secondary end point, the effect of implementation on mortality.
"Resuscitation compliance increased from 10.9% at baseline to 30.1% after 2 years," Dr. Levy said. "There was an almost linear increase [in compliance]. It was statistically significant with every quarter."
"Mortality dropped from 37% at baseline to 30% after 2 years," Dr. Levy reported. Although absolute risk reduction was 7%, relative risk reduction was 19% (P < .01), he added.
To analyze the significance of the drop in mortality, the investigators assessed the baseline mortality on hospital admission.
"Baseline mortality did not change, which suggests a true drop in mortality," Dr. Levy said. "The findings showed us 2 things. One, that we were able to change clinical practice and that we were able to facilitate a knowledge transfer; and 2, that there was a real change in mortality."
Panel moderator Jean-Louis Vincent, MD, PhD, FCCM, professor of intensive care at the University of Brussels and head of the Department of Intensive Care at Erasme University Hospital, in Belgium, commented that the mortality rate was lower than expected, "particularly with shock. It may be that people are treating these patients more aggressively, as an artifact of the study."
"We are very excited about the data," Dr. Levy said. "We view this as a tremendous success."
Dr. Levy receives support from Eli Lilly, Edwards Lifesciences, Philips Medical Systems, Novartis, and Biosite. Dr. Vincent has disclosed no relevant financial relationships.
Society of Critical Care Medicine (SCCM) 38th Critical Care Congress. Latebreaker. Presented February 2, 2009
Medscape Medical News © 2009 Medscape
Cite this: Martha Kerr . SCCM 2009: Sepsis Management "Bundles" Boost Guideline Implementation, Reduce Mortality - Medscape - Feb 03, 2009.