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Original Investigation
April 6, 2020

Association of a Care Bundle for Early Sepsis Management With Mortality Among Patients With Hospital-Onset or Community-Onset Sepsis

Author Affiliations
  • 1Department of Epidemiology and Public Health, University of Maryland, Baltimore
  • 2RAND Corporation, Santa Monica, California
  • 3David Geffen School of Medicine, UCLA (University of California, Los Angeles)
  • 4Division of Infectious Diseases, UCLA
  • 5Department of Health Policy and Management, Fielding School of Public Health, UCLA
  • 6Division of General Internal Medicine, UCLA
JAMA Intern Med. 2020;180(5):707-716. doi:10.1001/jamainternmed.2020.0183
Key Points

Question  What is the association of a care bundle for early sepsis management, the Early Management Bundle for Severe Sepsis/Septic Shock (SEP-1), and its components with mortality and organ dysfunction in hospitalized patients with community-onset or hospital-onset sepsis?

Findings  In this cohort study of 6404 patients, SEP-1–adherent care was not associated with reduced mortality or decreased vasopressor support among patients with sepsis in the emergency department (community-onset sepsis), patients first meeting sepsis criteria after arrival in an inpatient unit (hospital-onset sepsis), or the total sample. Multiple components of SEP-1 were associated with improved outcomes among patients with sepsis in the emergency department, a statistically significant finding.

Meaning  The SEP-1–adherent care was not associated with improved outcomes, but individual SEP-1 components were associated with benefit in patients with community-onset sepsis.

Abstract

Importance  The Early Management Bundle for Severe Sepsis/Septic Shock (SEP-1) is a quality metric based on a care bundle for early sepsis management. Published evidence on the association of SEP-1 with mortality is mixed and largely excludes cases of hospital-onset sepsis.

Objective  To assess the association of the SEP-1 bundle with mortality and organ dysfunction in cohorts with hospital-onset or community-onset sepsis.

Design, Setting, and Participants  This retrospective cohort study used data from 4 University of California hospitals from October 1, 2014, to October 1, 2017. Adult inpatients with a diagnosis consistent with sepsis or disseminated infection and laboratory or vital signs meeting the Sepsis-3 (Third International Consensus Definitions for Sepsis and Septic Shock) criteria were divided into community-onset sepsis and hospital-onset sepsis cohorts based on whether time 0 of sepsis occurred after arrival in the emergency department or an inpatient area. Data were analyzed from April to October 2019. Additional analyses were performed from December 2019 to January 2020.

Exposures  Administration of SEP-1 and 4 individual bundle components (serum lactate level testing, blood culture, broad-spectrum intravenous antibiotic treatment, and intravenous fluid treatment).

Main Outcomes and Measures  The primary outcome was in-hospital mortality. The secondary outcome was days requiring vasopressor support, measured as vasopressor days.

Results  Among the 6404 patient encounters identified (3535 men [55.2%]; mean [SD] age, 64.0 [18.2] years), 2296 patients (35.9%) had hospital-onset sepsis. Among 4108 patients (64.1%) with community-onset sepsis, 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%). Blood culture (absolute difference, –1.10 days; 95% CI, –1.85 to –0.34 days) and broad-spectrum intravenous antibiotic treatment (absolute difference, –0.62 days; 95% CI, –1.02 to –0.22 days) were associated with fewer vasopressor days. Among patients with hospital-onset sepsis, broad-spectrum intravenous antibiotic treatment was the only bundle component significantly associated with any improved outcome (mortality difference, –5.20%; 95% CI, –9.84% to –0.56%). Care that was adherent to the complete SEP-1 bundle was associated with increased vasopressor days in patients with community-onset sepsis (absolute difference, 0.31 days; 95% CI, 0.11-0.51 days) but was not significantly associated with reduced mortality in either cohort (absolute difference, –0.07%; 95% CI, –3.02% to 2.88% in community-onset; absolute difference, –0.42%; 95% CI, –6.77% to 5.93% in hospital-onset).

Conclusions and Relevance  SEP-1–adherent care was not associated with improved outcomes of sepsis. Although multiple components of SEP-1 were associated with reduced mortality or decreased days of vasopressor therapy for patients who presented with sepsis in the emergency department, only broad-spectrum intravenous antibiotic treatment was associated with reduced mortality when time 0 occurred in an inpatient unit. Current sepsis quality metrics may need refinement.

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