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Evidence Underpinning the Centers for Medicare & Medicaid Services’ Severe Sepsis and Septic Shock Management Bundle (Sep-1). a Systematic Review
Pepper DJ, Jaswal D, Sun J, et al. Ann Intern Med. 2018; 168.
Study Question: Is there moderate or high-level evidence to demonstrate the use of the 2015 SEP-1 or the hemodynamic based interventions leads to improved survival in sepsis?
Study Description: The authors conducted a systematic literature review of randomized and observational studies through November 2017. Trials were considered if included patients were diagnosed with sepsis, severe sepsis, or septic shock and the study compared mortality rates in patients receiving versus not receiving at least one of the following: serial lactate measurements, 30 mL/kg fluid infusions, or other assessment of volume and perfusion (SEP-1 hemodynamic interventions). Four investigators, using the Centers for Medicare & Medicaid Services (CMS) criteria published in 2013, rated each full-text meeting inclusion criteria. The primary outcome was the effect of the SEP-1 bundle and the SEP-1 hemodynamic interventions on mortality.
Results: A total of 56,563 references were identified through the literature search, and 527 full-text articles were reviewed. There were 20 studies comparing the effect of the SEP-1 hemodynamic interventions on mortality. Sixteen trials, 2 randomized, found an improvement in survival with the use of serial lactate measurements or fluid infusions. Of the 17 studies demonstrating an improvement in survival, none were either free of confounders nor at a low risk of bias. There were three randomized trials evaluating the usefulness of measurements of fluid responsiveness, none of which altered survival.
Conclusion(s): There is no high or moderate-level evidence demonstrating that SEP-1 or its hemodynamic interventions improve morality in sepsis.
Perspective: Only low-level evidence supports the use of the hemodynamic interventions in the SEP-1 bundle, and the systematic review does not demonstrate the safety of the SEP-1 interventions. Several large trials (ProCESS, ARISE, and ProMISE) have not shown an effect of a 30 mL/kg fluid infusion on mortality. It should also be noted that only a single observational study, evaluated the full SEP-1 bundle. The lack of high quality evidence to support SEP-1 interventions suggests clinicians should use a more patient-centered than protocol-centered approach to the hemodynamic management of sepsis. CMS should reconsider the inclusion of measures of fluid-responsiveness in the SEP-1 bundle.