Validation of the new sepsis-3 definitions: proposal for improvement in early risk identification.
Clin Microbiol Infect. 2016 Nov 14;:
Authors: Giamarellos-Bourboulis EJ, Tsaganos T, Tsangaris I, Lada M, Routsi C, Sinapidis D, Koupetori M, Bristianou M, Adamis G, Mandragos K, Dalekos GN, Kritselis I, Giannikopoulos G, Koutelidakis I, Pavlaki M, Antoniadou E, Vlachogiannis G, Koulouras V, Prekates A, Dimopoulos G, Koutsoukou A, Pnevmatikos I, Ioakeimidou A, Kotanidou A, Orfanos SE, Armaganidis A, Gogos C, Hellenic Sepsis Study Group
OBJECTIVES: Sepsis-3 definitions generated controversies regarding their general applicability. The Sepsis-3 Task Force outscored the need of validation with emphasis on quick SOFA (qSOFA) score. This was done in a prospective cohort coming from a different health-care setting.
METHODS: Patients with infections and at least two signs of the systemic inflammatory response syndrome (SIRS) were analyzed. Sepsis was defined as total SOFA ≥2 outside the ICU or as increase of ICU admission SOFA ≥2. The primary endpoint was the sensitivity of qSOFA outside the ICU and sepsis definition both outside and in the ICU to predict mortality.
RESULTS: 3,346 infections outside the ICU and 1,058 infections in the ICU were analyzed. Outside the ICU, respective mortality with ≥2 SIRS and qSOFA ≥2 was 25.3% and 41.2% (p<0.0001); the sensitivities of qSOFA and of sepsis definition to predict death were 60.8% and 87.2% respectively. This was 95.9% for sepsis definition in the ICU. The sensitivity of qSOFA and of ≥3 SIRS criteria for organ dysfunction outside the ICU was 48.7% and 72.5% respectively (p< 0.0001). Misclassification outside the ICU with the 1991 and sepsis-3 definitions into stages of lower severity was 21.4% and 3.7% respectively (p< 0.0001) and 14.9% and 3.7% respectively in the ICU (p< 0.0001). Adding arterial pH≤7.30 to qSOFA increased sensitivity for death to 67.5% (p: 0.004).
CONCLUSIONS: Our analysis positively validated the use of SOFA score to predict unfavorable outcome and to limit misclassification into lower severity. However, qSOFA score had inadequate sensitivity for early risk assessment.
PMID: 27856268 [PubMed - as supplied by publisher]