Background: The Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), the sepsis performance measure introduced by the Centers for Medicare & Medicaid Services (CMS), requires up to 5 hemodynamic interventions, as many as 141 tasks, and 3 hours to document for a single patient. Purpose: To evaluate whether moderate- or high-level evidence shows that use of SEP-1 or its hemodynamic interventions improves survival in adults with sepsis.
Data Sources: PubMed, Embase, Scopus, Web of Science, and ClinicalTrials.gov from inception to 28 November 2017 with no language restrictions.
Study Selection: Randomized and observational studies of death among adults with sepsis who received versus those who did not receive either the entire SEP-1 bundle or 1 or more SEP-1 hemodynamic interventions, including serial lactate measurements; a fluid infusion of 30 mL/kg of body weight; and assessment of volume status and tissue perfusion with a focused examination, bedside cardiovascular ultrasonography, or fluid responsiveness testing.
Data Extraction: Two investigators independently extracted study data and assessed each study's risk of bias; 4 authors rated level of evidence by consensus using CMS criteria. High- or moderate-level evidence required studies to have no confounders and low risk of bias.
Data Synthesis: Of 56 563 references, 20 studies (18 reports) met inclusion criteria. One single-center observational study reported lower in-hospital mortality after implementation of the SEP-1 bundle. Sixteen studies (2 randomized and 14 observational) reported increased survival with serial lactate measurements or 30-mL/kg fluid infusions. None of the 17 studies were free of confounders or at low risk of bias. In 3 randomized trials, fluid responsiveness testing did not alter survival.
Limitation: Few trials, poor-quality and confounded studies, and no studies (with survival outcomes) of the focused examination or bedside cardiovascular ultrasonography.
Conclusion: No high- or moderate-level evidence shows that SEP-1 or its hemodynamic interventions improve survival in adults with sepsis.
In the accompanying Editorial John Kress and Jesse Hall conclude that ” Enforcing a cookbook approach to management of a syndrome as complex as sepsis is unwise because it may shackle thoughtful consideration of each case's nuances. It would be unfortunate if government mandates like SEP-1 fostered mediocrity at the cost of excellence.”
The elements that make up SEP-1 (previously reviewed on this site) are devoid of any supporting scientific evidence and the systematic review by Pepper et al suggest that this mandate may be harmful to patients. It is mind-boggling and in-explainable why the US Federal Government would mandate an intervention which is potentially harmful to patients and extremely costly in terms of wasted resources. It has been suggested that SEP-1 may be the result of a conspiracy by “foreign powers” to undermine the health of Americans. When asked to comment on this paper at the most recent SCCM annual meeting, Dr Sean Townsend (the chief architect of SEP-1) responded that this paper was “FAKE-NEWS”.