PITTSBURGH, March 21, 2017
– In a feat of medical and scientific coordination, doctors across 138 hospitals in seven countries shared treatment protocols and harmonized data collection of three clinical trials resulting in the most comprehensive analysis to date on care for sepsis, the leading killer of hospital patients worldwide. The international evaluation was overseen by physicians at the University of Pittsburgh School of Medicine
, who expect the work to serve as a model for future research of this scale.
“These results are reassuring because we’ve already been changing sepsis care based on individual findings from the three trials,” said Derek Angus, M.D., M.P.H.
, Distinguished Professor and Mitchell P. Fink Chair, Department of Critical Care Medicine
at Pitt, and principal investigator of the U.S. trial, which was the first of the three to get funded. “What is truly inspiring is how we have collaborated across oceans to garner outcomes powerful enough to grant us this validation and confidence when caring for our sickest patients.”
arises when the body’s response to an infection injures its own tissues and organs, sometimes progressing to septic shock. According to the National Institutes of Health
, it may occur in more than 1 million U.S. patients every year, and—despite best practice—an estimated 28 to 50 percent of these people do not survive.
Before enrolling a single patient, the scientists leading each trial worked together
to ensure that their trials tested treatments and collected information in a way that would make the findings compatible. In doing so, the scientists effectively tripled their data, allowing more detailed analyses compared to any single trial.
The combined meta-analysis of the three trials included 3,723 sepsis patients, approximately half treated with “usual care,” in which the bedside physician directs the course of treatment based on what he or she determines is best for the patient, and the other half treated with EDGT, which requires the clinician to follow a protocol that includes placing a catheter called a central line in the jugular vein to monitor blood pressure and oxygen levels, as well as delivery of drugs, fluids and blood transfusions.
The meta-analysis determined that EGDT did not improve patient outcome and increased hospitalization costs when compared with usual care, supporting previously announced findings from the ProCESS trial. More simply stated, good early bedside sepsis care
with therapies matched to severity is key, not use of a singular protocol.
“Randomized clinical trials are the gold standard of medicine, but are very difficult and expensive to perform, and are best when merged with data from other trials to get the best picture possible,” said Donald M. Yealy, M.D.
, professor and chair of Pitt’s Department of Emergency Medicine
and lead author of the previous ProCESS trial publication
. “However, merging such data is a challenge because often the information is not collected consistently across trials. We planned ahead, two years before these three big sepsis trials started, and created an approach allowing each trial to not only stand on its own, but also be able to contribute to a ‘whole’ that is greater than the ‘sum of its parts.’”
At Pitt, additional study authors are Amber E. Barnato, M.D., M.Sc., Elizabeth Gimbel, R.N., B.S., David T. Huang, M.D., M.P.H., John A. Kellum, M.D., and Edvin Music, M.S.I.S., M.B.A.