• Jonathan D Baghdadi, Robert H Brook, Daniel Z Uslan, Jack Needleman, Douglas S Bell, William E Cunningham, and Mitchell D Wong.
• Department of Epidemiology and Public Health, University of Maryland, Baltimore.
• JAMA Intern Med. 2020 May 1; 180 (5): 707-716.

ImportanceThe 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.ObjectiveTo 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 ParticipantsThis 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.ExposuresAdministration 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 MeasuresThe primary outcome was in-hospital mortality. The secondary outcome was days requiring vasopressor support, measured as vasopressor days.ResultsAmong 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 RelevanceSEP-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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