Clinical Evaluation of Sepsis-1 and Sepsis-3 in the ICU

Background: There has been considerable controversy between sepsis-1 and sepsis-3 criteria.

Methods: Patients with infection meeting two or more systemic inflammatory response syndrome (SIRS) criteria (sepsis-1) or a Sequential Organ Failure Assessment (SOFA) score ≥ 2 (sepsis-3) on the first day after ICU admission were selected from the Medical Information Mart for Intensive Care-III database, and their outcomes were compared using all-cause death as the end point. Subgroup analysis was also performed based on prior chronic organ dysfunction.

Results: There were 21,491 infected patients included. Of those meeting the diagnostic criteria for sepsis-1, 13.42% did not satisfy sepsis-3 criteria, and this population had a 21-day mortality rate of 6.96%. In contrast, 7.00% of the patients meeting sepsis-3 criteria did not meet sepsis-1 criteria, and their 21-day mortality rate was 10.76%. When excluding preexisting organ conditions, 18.41% of patients with sepsis-1 did not meet sepsis-3 criteria, with a 21-day mortality rate of 6.39%, and 6.00% of patients with sepsis-3 did not meet sepsis-1 criteria, with a 21-day mortality rate of 9.11%. When two or more SIRS criteria or SOFA score ≥ 2 were applied to predict 21-day all-cause mortality in infected patients without prior chronic organ dysfunction, the sensitivity was 96.0% or 91.0%, respectively. Although the areas under the receiver operator curve of both SOFA and SIRS criteria could be used for predicting mortality, SOFA score represented the severity of the condition, whereas SIRS score represented a clinically evident host response to infection.

Conclusions: Sepsis-3 diagnostic criteria narrow the sepsis population at the expense of sensitivity, and the resulting false negatives may delay disease diagnosis. It may be inappropriate to compare the prediction performance of SIRS and SOFA criteria when sepsis-3 is defined.