The early change of SOFA score as a prognostic marker of 28-day sepsis mortality: analysis through a derivation and a validation cohort

Eleni Karakike,Evdoxia Kyriazopoulou,Iraklis Tsangaris,Evangelos J Giamarellos-Bourboulis,Christina Routsi,Jean-Louis Vincent

doi:10.1186/s13054-019-2665-5

Eleni Karakike, Evdoxia Kyriazopoulou + Show 4 more

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BackgroundSince the Sepsis-3 criteria, change in Sequential Organ Failure Assessment (SOFA) score has become a key component of sepsis identification. Thus, it could be argued that reversal of this change (ΔSOFA) may reflect sepsis response and could be used as measure of efficacy in interventional trials. We aimed to assess the predictive performance of ΔSOFA for 28-day mortality.MethodsData from two previously published randomized controlled trials were studied: the first reporting on patients with severe Gram-negative infections as a derivation cohort and the second reporting on patients with ventilator-associated pneumonia as a validation cohort. Only patients with sepsis according to the Sepsis-3 definition were included in this analysis. SOFA scores were calculated on days 1, 2, 3, 5, 7, 14, and 28.ResultsWe included 448 patients within the derivation cohort and 199 within the validation cohort. Mean SOFA scores on day 1 were 6.06 ± 4.07 and 7.84 ± 3.39, and 28 day mortality 22.8% and 29.6%, respectively. In the derivation cohort, the earliest time point where ΔSOFA score predicted mortality was day 7 (AUROC (95% CI) 0.84 (0.80–0.89); p < 0.001). The best tradeoff for prediction was found with 25% changes (78% sensitivity, 80% specificity); less than 25% decrease of admission SOFA was associated with increased mortality (odds ratio for death 14.87). This finding was confirmed in the validation cohort.ConclusionsΔSOFA on day 7 is a useful early prognostic marker of 28-day mortality and could serve as an endpoint in future sepsis trials alongside mortality.Trial registrationClinicalTrials.gov numbers NCT01223690 and NCT00297674

Highlights

Since the Sepsis-3 criteria, change in Sequential Organ Failure Assessment (SOFA) score has become a key component of sepsis identification
When the area under the respective receiver operator characteristics (AUROC) of Delta SOFA (ΔSOFA) of follow-up days were compared, it was found that the earliest time point when the achieved AUROC was greater than previous days was on day 7 (Fig. 2b)
Our analysis focused on the development of a specific value of ΔSOFA of day 7 as an early predictor of 28-day mortality

Summary

Introduction

Since the Sepsis-3 criteria, change in Sequential Organ Failure Assessment (SOFA) score has become a key component of sepsis identification. Institutes of Health (FNIH) on the update of primary endpoint definitions for non-inferiority trials for the management of infectious diseases. The former test-of-cure visit usually taking place 7–14 days after end of treatment was replaced by the early response 48–72 h after start of treatment for acute bacterial skin and soft structure infections [6] and 3–5 days after start of treatment for community-acquired pneumonia [7], while efforts are being made to expand this concept to hospital-acquired and ventilator-associated pneumonia [8, 9]. With the Sepsis-3 classification criteria, the Sequential Organ Failure Assessment (SOFA) score is used as a measure of sepsis-associated organ dysfunction. It is reasonable to define the earliest time point during the course of the disease where a clinical meaningful change of the baseline SOFA score is achieved

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