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Invited Commentary
April 6, 2020

How Effective Is the Early Management Bundle for Severe Sepsis/Septic Shock?

Author Affiliations
  • 1PGY3 Emergency Medicine Resident, SUNY Downstate Medical Center, Kings County Hospital, NYC Health + Hospitals, New York
  • 2Department of Emergency Medicine, SUNY Downstate Medical Center, Kings County Hospital, NYC Health + Hospitals, New York
JAMA Intern Med. 2020;180(5):716-717. doi:10.1001/jamainternmed.2020.0180

Sepsis is a significant cause of mortality, and improving survival has gained a lot of attention over the last 2 decades as a measure for quality improvement. Mortality rates from sepsis as high as 49.7%1 were the stimulus for Rivers et al2 to develop early goal-directed therapy in 2001, resulting in significantly lower mortality rates (30.5%). In 2002, the Surviving Sepsis Campaign, an international effort led by intensivists, began promoting early recognition and treatment of sepsis. This campaign ultimately led to the adoption of Early Management Bundle for Severe Sepsis/Septic Shock (SEP-1) by the US Centers for Medicare & Medicaid Services (CMS) in October 2015. At almost the same time, 3 randomized clinical trials of early goal-directed therapy vs usual care were published. The Protocolised Care for Early Septic Shock (ProCESS) trial,3 Australasian Resuscitation in Sepsis Evaluation (ARISE) trial,4 and Protocolised Management in Sepsis (ProMISe) trial5 found no survival benefit in patients with sepsis between early goal-directed therapy and usual care. The final version of the SEP-1 bundle adopted by CMS removed the invasive monitoring requirement from early goal-directed therapy and adopted the fluid volume and the repeated lactate metrics without significant evidenced-based support.

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