21 May Rory’s Regulations: Faster Is Better When It Comes To Sepsis Care
MedicalResearch.com Interview with:
Christopher W. Seymour, M.D., M.Sc.
Assistant professor of Critical Care Medicine and Emergency Medicine, and member of Clinical Research Investigation and Systems Modeling of Acute Illness
University of Pittsburgh
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Following the tragic and widely publicized death of Rory Staunton, 12, from undiagnosed sepsis in 2012, New York became the first state to require that hospitals follow a protocol to quickly identify and treat the condition. The mandate led to widespread controversy in the medical community as to whether such steps would have saved Rory or anyone else’s life.
Rory’s Regulations require hospitals to follow protocols for early identification and treatment of sepsis, and submit data on compliance and outcomes. The hospitals can tailor how they implement the protocols, but must include a blood culture to test for infection, measurement of blood lactate (a sign of tissue stress) and administration of antibiotics within three hours of diagnosis—collectively known as the “three-hour bundle.”
We analyzed data from nearly 50,000 patients from 149 New York hospitals to scientifically determine if Rory’s Regulations worked. We found that they did – 83 percent of the hospitals completed the bundle within the required three hours, overall averaging 1.3 hours for completion. For every hour that it took clinicians to complete the bundle, the odds of the patient dying increased by 4 percent.
MedicalResearch.com: What should readers take away from your report?
Response: There is considerable controversy about how rapidly sepsis must be treated. Some question the benefit of rapid treatment with protocols, saying they can have unintended side effects and be a distraction in busy emergency departments. After reviewing the data, we can finally say that faster is better when it comes to sepsis care.
When the patient is newly diagnosed and possibly still in the emergency department is when it is most important to check the boxes of the three-hour bundle. Minutes matter, and it is critical to perform the correct tests and get the patient antibiotics as fast as possible.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: A randomized control trial is the gold standard for determining if a treatment method is successful. That is a very difficult undertaking with sepsis, but I would like to see that done in the future.
More immediately, to our surprise, we found that faster administration of intravenous fluid in sepsis was less helpful than early antibiotics or the three-hour bundle. And, although most hospitals in New York used protocols the same way, many completed the three-hour bundle much later than expected. Further investigation is needed to learn more about both of these findings.
Mitchell Levy, M.D., professor of medicine in the Warren Alpert Medical School of Brown University is senior author on this study. Our co-authors are Hallie C. Prescott, M.D., M.Sc., Theodore J. Iwashyna, M.D., Ph.D., both of the University of Michigan and VA Center for Clinical Management Research in Ann Arbor, Mich.; Foster Gesten, M.D., and Marcus Friedrich, M.D., M.B.A., of the New York State Department of Health; Gary S. Phillips, M.A.S., and Kathy M. Terry, Ph.D., both of IPRO in Lake Success, New York; Stanley Lemeshow, Ph.D., of Ohio State University; and Tiffany Osborn, M.D., M.P.H., of Washington University.
This research was supported by National Institutes of Health grants R35GM119519 and K08GM115859, and VA Health Services Research & Development grant 11-109 13-079. Phillips received personal fees from IPRO for conducting statistical analyses.
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May 21, 2017DOI: 10.1056/NEJMoa1703058
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