Adherence to the SEP-1 sepsis bundle — a quality care metric for managing early sepsis — is not associated with improved outcomes, researchers found.

Jonathan D. Baghdadi, MD, PhD, Department of Epidemiology and Public Health, University of Maryland, Baltimore, and colleagues determined that compliance with the SEP-1 (Early Management Bundle for Severe Sepsis/Septic Shock) sepsis bundle was not associated with reduced mortality or decreased vasopressor support among patients with sepsis.

They did find, however, that individual components of the SEP-1 bundle were associated with improved outcomes in patients presenting with community-onset sepsis.

The study was published in JAMA Internal Medicine.

As explained by the authors, most patients with sepsis exhibit signs and symptoms at the time of hospital admission (community-onset sepsis), while a smaller percentage (10%-20%) develop symptoms after hospital admission.

The SEP-1 bundle is recommended for all patients with sepsis, including those with community-onset and hospital-onset sepsis. However, Baghdadi and colleagues pointed out that these sepsis bundles have mostly been studied in the context of community-onset sepsis, and less so in hospital-onset sepsis.

Here, the authors wanted to evaluate the usefulness of SEP-1 as a quality metric by assessing its association with mortality and organ dysfunction in both patients with community- and hospital-onset sepsis.

For purposes of this retrospective cohort study Baghdadi and colleagues collected data from 4 academic teaching hospitals — Ronald Reagan Medical Center, Los Angeles, California; Santa Monica Hospital, Santa Monica, California; Jacobs Medical Center, La Jolla, California; and University of San Diego Medical Center, Hillcrest, San Diego, California.

The authors identified 6404 patients (adults 18 years and older) from Oct. 1, 2014, to Oct. 1, 2017 who presented with a diagnosis consistent with sepsis or disseminated infection, and laboratory or vital signs meeting the Sepsis-3 definition of sepsis (per the Third International Consensus Definitions for Sepsis and Septic Shock).

The primary outcome of the study was in-hospital mortality, while the secondary outcome was days requiring vasopressor support. The treatments evaluated in the study included the SEP-1 bundle and four individual components: serum lactate level testing, blood culture, broad-spectrum intravenous antibiotic treatment, and intravenous fluid treatment.

Of the 6,404 patients, 2,296 (35.9%) had hospital-onset sepsis while the remaining 4,108 (64.1%) had community onset sepsis.

Care that adhered to the SEP-1 bundle was not significantly associated with reduced mortality in either community-onset sepsis (absolute mortality difference, –0.07%; 95% CI, –3.02% to 2.88%) or hospital-onset sepsis (absolute mortality difference, –0.42%; 95% CI, –6.77%-5.93%). It was associated with increased vasopressor days in patients with community-onset sepsis (absolute difference, 0.31 days; 95% CI, 0.11-0.51 days).

As for individual components:

  • Serum lactate level testing within 3 hours of time 0 was associated with reduced mortality (absolute difference, –7.61%; 95% CI, –14.70% to –0.54%) among the patients with community-onset sepsis.
  • Blood culture (absolute difference, –1.10 days; 95% CI, –1.85 to –0.34 days) was associated with fewer vasopressor days among the patients with community-onset sepsis.
  • Broad-spectrum intravenous antibiotic treatment (absolute difference, –0.62 days; 95% CI, –1.02 to –0.22 days) was also associated with fewer vasopressor days in those patients.

Among patients with hospital-onset sepsis, broad-spectrum intravenous antibiotic treatment was significantly associated with reduced mortality (difference, –5.20%; 95% CI, −9.84% to –0.56%). It was the only bundle component associated with any improved outcome in hospital-onset sepsis.

The results suggest that sepsis quality metrics “may need refinement,” Baghdadi and colleagues concluded.

In a commentary accompanying the study, Hannah Moreira, MD, and Richard Sinert, DO, both of the SUNY Downstate Medical Center, Kings County Hospital, NYC Health + Hospitals, New York wrote that the study “shows that one size does not fit all when determining the best treatment for potentially septic patients.”

They suggested that studies showing no mortality benefit with the SEP-1 bundle should encourage the Centers for Medicare and Medicaid Services to consider a more individualized approach to caring for patients who are critically ill with sepsis.

“Sepsis care should be limited to only those who appear to be in septic shock, emphasizing early antibiotics and acknowledging physician judgment concerning the volume of fluids infused and the role of lactate measurements in the care of these patients,” they concluded.