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. To evaluate whether moderate- or high-level evidence shows that use of SEP-1 or its hemodynamic interventions improves survival in adults with sepsis.

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.

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.

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. Few trials, poor-quality and confounded studies, and no studies (with survival outcomes) of the focused examination or bedside cardiovascular ultrasonography.

No high- or moderate-level evidence shows that SEP-1 or its hemodynamic interventions improve survival in adults with sepsis.