Association Between the New York Sepsis Care Mandate and In-Hospital Mortality for Pediatric Sepsis

Abstract

Importance: The death of a pediatric patient with sepsis motivated New York to mandate statewide sepsis treatment in 2013. The mandate included a 1-hour bundle of blood cultures, broad-spectrum antibiotics, and a 20-mL/kg intravenous fluid bolus. Whether completing the bundle elements within 1 hour improves outcomes is unclear.

Objective: To determine the risk-adjusted association between completing the 1-hour pediatric sepsis bundle and individual bundle elements with in-hospital mortality.

Design, settings, and participants: Statewide cohort study conducted from April 1, 2014, to December 31, 2016, in emergency departments, inpatient units, and intensive care units across New York State. A total of 1179 patients aged 18 years and younger with sepsis and septic shock reported to the New York State Department of Health who had a sepsis protocol initiated were included.

Exposures: Completion of a 1-hour sepsis bundle within 1 hour compared with not completing the 1-hour sepsis bundle within 1 hour.

Main outcomes and measures: Risk-adjusted in-hospital mortality.

Results: Of 1179 patients with sepsis reported at 54 hospitals (mean [SD] age, 7.2 [6.2] years; male, 54.2%; previously healthy, 44.5%; diagnosed as having shock, 68.8%), 139 (11.8%) died. The entire sepsis bundle was completed in 1 hour in 294 patients (24.9%). Antibiotics were administered to 798 patients (67.7%), blood cultures were obtained in 740 patients (62.8%), and the fluid bolus was completed in 548 patients (46.5%) within 1 hour. Completion of the entire bundle within 1 hour was associated with lower risk-adjusted odds of in-hospital mortality (odds ratio [OR], 0.59 [95% CI, 0.38 to 0.93], P = .02; predicted risk difference [RD], 4.0% [95% CI, 0.9% to 7.0%]). However, completion of each individual bundle element within 1 hour was not significantly associated with lower risk-adjusted mortality (blood culture: OR, 0.73 [95% CI, 0.51 to 1.06], P = .10; RD, 2.6% [95% CI, -0.5% to 5.7%]; antibiotics: OR, 0.78 [95% CI, 0.55 to 1.12], P = .18; RD, 2.1% [95% CI, -1.1% to 5.2%], and fluid bolus: OR, 0.88 [95% CI, 0.56 to 1.37], P = .56; RD, 1.1% [95% CI, -2.6% to 4.8%]).

Conclusions and relevance: In New York State following a mandate for sepsis care, completion of a sepsis bundle within 1 hour compared with not completing the 1-hour sepsis bundle within 1 hour was associated with lower risk-adjusted in-hospital mortality among patients with pediatric sepsis and septic shock.

Figure 1.

Patient Accrual

Figure 2.

Risk-Adjusted Odds Ratios of In-Hospital Death in the Primary Models Embedded table reports the total number of patients, total number of absolute deaths (%), predicted risk from adjusted models and risk difference (95% CI), and odds ratios (95% CI) comparing patients who did and did not complete the 1 hour bundle within 1 hour. Variables in the risk-adjusted model include age category, payer, protocol initiation site, diagnosis of septic shock, site of infection, platelet count <150 000/μL at protocol initiation, chronic renal disease or liver failure, diabetes, acute respiratory failure requiring mechanical ventilation at protocol initiation, serum lactate, and transfer status.

Figure 3.

Crude In-Hospital Mortality and Predicted Risk of In-Hospital Death After the Time of Sepsis Protocol Initiation Crude in-hospital mortality (bars) and the predicted risks of in-hospital death with 95%CIs (orange line with error bars). Predicted risks derive from model adjusted for age category, payer, protocol initiation site, diagnosis of septic shock, site of infection, platelet count <150 000μL at protocol initiation, chronic renal failure or renal disease, diabetes, acute respiratory failure requiring mechanical ventilation, serum lactate, and transfer status across 4 hours after protocol initiation for the completion of the 1-hour bundle of sepsis care. As an interpretive example, for a typical pediatric patient with sepsis with average age and level of acuity in New York State, the completion of the 1-hour sepsis bundle within 1 hour was associated with an 8% risk of in-hospital death. In contrast, the same patient who completes the bundle at 4 hours will have a 13% predicted risk of in-hospital death.

Figure 4.

Risk and Reliability-Adjusted Rate for Each Hospital for Completion of the 1-Hour Bundle in 1 Hour, According to Hospital Rank The 54 hospitals that were included in the study were ranked from lowest to highest, with higher numbers (x-axis) indicating a greater likelihood of completing the 1-hour bundle within 1 hour. Bars represents 95% CIs. Orange circles correspond to hospitals with both pediatric intensive care and cardiac surgery services. Risk and reliability adjustment accounts for both patient-level risk factors that may influence outcome and statistical variation attributed to small sample sizes at the level of the hospital. These adjustments allow for accurate comparisons between hospitals of different patient volume and case mix.