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. 2017 Feb;23(2):104-109.
doi: 10.1016/j.cmi.2016.11.003. Epub 2016 Nov 14.

Validation of the new Sepsis-3 definitions: proposal for improvement in early risk identification

E J Giamarellos-Bourboulis  1 , T Tsaganos  2 , I Tsangaris  3 , M Lada  4 , C Routsi  5 , D Sinapidis  6 , M Koupetori  7 , M Bristianou  8 , G Adamis  9 , K Mandragos  10 , G N Dalekos  11 , I Kritselis  12 , G Giannikopoulos  13 , I Koutelidakis  14 , M Pavlaki  15 , E Antoniadou  16 , G Vlachogiannis  17 , V Koulouras  18 , A Prekates  19 , G Dimopoulos  3 , A Koutsoukou  20 , I Pnevmatikos  21 , A Ioakeimidou  22 , A Kotanidou  5 , S E Orfanos  3 , A Armaganidis  3 , C Gogos  23 ; Hellenic Sepsis Study Group
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Free article

Validation of the new Sepsis-3 definitions: proposal for improvement in early risk identification

E J Giamarellos-Bourboulis et al. Clin Microbiol Infect. 2017 Feb.
Free article

Abstract

Objectives: Sepsis-3 definitions generated controversies regarding their general applicability. The Sepsis-3 Task Force outlined the need for validation with emphasis on the quick Sequential Organ Failure Assessment (qSOFA) score. This was done in a prospective cohort from a different healthcare setting.

Methods: Patients with infections and at least two signs of systemic inflammatory response syndrome (SIRS) were analysed. Sepsis was defined as total SOFA ≥2 outside the intensive care unit (ICU) or as an increase of ICU admission SOFA ≥2. The primary endpoints were the sensitivity of qSOFA outside the ICU and sepsis definition both outside and within the ICU to predict mortality.

Results: In all, 3346 infections outside the ICU and 1058 infections in the ICU were analysed. 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 prediction of death to 67.5% (p 0.004).

Conclusions: Our analysis positively validated the use of SOFA score to predict unfavourable outcome and to limit misclassification into lower severity. However, qSOFA score had inadequate sensitivity for early risk assessment.

Keywords: Definitions; Infection; Mortality; Sepsis; Septic shock.

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