Drs. Angus, Yealy and Fink, all from the University of Pittsburgh, helped to secure the $8.4 million grant from the National Institute of General Medical Sciences (NIGMS), part of the National Institutes of Health (NIH). The consortium, a partnership between physicians in emergency medicine and those in critical care medicine, will work to speed recovery, increase survival rates and improve the long-term quality of life for those who develop sepsis. The motivation for the study was the landmark single-center trial of EGDT published by Emanuel Rivers, MD, MPH, in the November 8, 2001, edition of the New England Journal of Medicine. The goals of ProCESS are to understand whether and how well EGDT can work across broad settings as well as to explore the mechanisms of action of EGDT and its cost-effectiveness.

The first year will be spent training sepsis teams at 15 to 20 hospitals of various sizes throughout the United States. During the next two to three years, these hospitals will enroll up to 2,000 patients, randomly selected to be treated by standard care or by a sepsis team delivering the EGDT protocol. The researchers hope to test two versions of the EGDT protocol: the full protocol first introduced by Dr. Rivers and a more pragmatic version that uses only certain aspects. The latter would be based on bedside examination criteria, vasopressor use and aggressive fluid resuscitations and not on central venous oxygen measurements. Patients will be tracked for one year after their recovery to detect long-term differences in health and mortality rates. Like trauma teams, these sepsis teams will include doctors, nurses, respiratory therapists, emergency room personnel and other members of the multiprofessional team. If the study results are positive, they will likely spur widespread change in the management of early sepsis and severe infection in the United States.
 
“We think that finding out whether EGDT performed by a sepsis team is effective, whether it’s the full Rivers protocol or a shortened version, is worthwhile even if it only drops mortality by four or five percent. It’s still important to find,” Dr. Angus said. By measuring changes in a number of biomarkers of injury, researchers hope to learn more about why EGDT works. “We hope to really get an understanding of sepsis and what’s driving the organ dysfunction,” added Dr. Fink. The study is expected to shed light on how hospitals can use EGDT effectively to help save lives and will help foster the relationship between the emergency department and critical care department at participating hospitals. “The point isn’t who is doing it, its whether it is getting done,”
Yealy said. “We know you have to work together and work early to help these patients get better.”