Implications of Centers for Medicare & Medicaid Services Severe Sepsis and Septic Shock Early Management Bundle and Initial Lactate Measurement on the Management of Sepsis

Abstract

Background: Sepsis remains a significant cause of morbidity and mortality in the United States, leading to the implementation of the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1). SEP-1 identifies patients with "severe sepsis" via clinical and laboratory criteria and mandates interventions, including lactate draws and antibiotics, within a specific time window. We sought to characterize the patients affected and to study the implications of SEP-1 on patient care and outcomes.

Methods: All adults admitted to the University of Chicago from November 2008 to January 2016 were eligible. Modified SEP-1 criteria were used to identify appropriate patients. Time to lactate draw and antibiotic and IV fluid administration were calculated. In-hospital mortality was examined.

Results: Lactates were measured within the mandated window 32% of the time on the ward (n = 505) compared with 55% (n = 818) in the ICU and 79% (n = 2,144) in the ED. Patients with delayed lactate measurements demonstrated the highest in-hospital mortality at 29%, with increased time to antibiotic administration (median time, 3.9 vs 2.0 h). Patients with initial lactates > 2.0 mmol/L demonstrated an increase in the odds of death with hourly delay in lactate measurement (OR, 1.02; 95% CI, 1.0003-1.05; P = .04).

Conclusions: Delays in lactate measurement are associated with delayed antibiotics and increased mortality in patients with initial intermediate or elevated lactate levels. Systematic early lactate measurement for all patients with sepsis will lead to a significant increase in lactate draws that may prompt more rapid physician intervention for patients with abnormal initial values.

Keywords: critical care; lactic acid; sepsis; septic shock.

Figure 1

Flow diagram of study patients. Suspicion of infection is defined as any patient that had a blood culture ordered. ICD = International Classification of Diseases; SEP-1 = Severe Sepsis and Septic Shock Early Management Bundle; SIRS = systemic inflammatory response syndrome.

Figure 2

Percent of patients who had lactates drawn within Centers for Medicare & Medicaid Services window, by location.

Figure 3

Distribution of lactate levels drawn within Centers for Medicare & Medicaid Services SEP-1 window. See Figure 1 legend for expansion of abbreviation.

Figure 4

Relationship between delay in initial lactate measurement and the probability of in-hospital mortality for patients meeting SEP-1 criteria, stratified by level of initial lactate value (mmol/L) and adjusted for patient location, Electronic Cardiac Arrest Risk Triage score, and lactate value. See Figure 1 legend for expansion of other abbreviation.