Effectiveness of corticosteroids in patients with sepsis or septic shock using the new third international consensus definitions (Sepsis-3): A retrospective observational study

• Published in: PloS one 2020-12, Vol.15 (12), p.e0243149-e0243149
• Main Authors: Wu, Yu-Pu, Lauffenburger, Julie C
• Format: Article
• Language: English
• Subjects: Adrenal Cortex Hormones - therapeutic use; Aged; Aged, 80 and over; Algorithms; Biology and Life Sciences; Cancer therapies; Chronic obstructive pulmonary disease; Clinical trials; Corticoids; Corticosteroid drugs; Corticosteroids; Disease; Dosage and administration; Drug therapy; Electronic Health Records; Female; Hospitals; Humans; Infections; Intensive Care Units; Intravenous administration; Laboratories; Male; Medicine and Health Sciences; Middle Aged; Mortality; Observational studies; Patient outcomes; Patients; Public health; Research and Analysis Methods; Retrospective Studies; Sepsis; Sepsis - drug therapy; Septic shock; Shock, Septic - drug therapy; Survival; Survival Analysis; Treatment Outcome; Validation studies; Vital signs
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0243149

The effects of intravenous corticosteroids in patients with sepsis remain controversial due to mixed results from randomized trials. Moreover, updated definitions of sepsis, Sepsis-3, were proposed in 2016, and findings related to the effects of corticosteroids in patients defined by the Sepsis-3 criteria are scarce. To investigate the effectiveness of corticosteroids in patients with sepsis or septic shock using real-world data to complement the findings of randomized controlled trials, and to determine whether the treatment effects differ by sepsis definitions. We conducted this study by utilizing a large, multi-center healthcare database, eICU, in which we identified patients with sepsis admitted to 208 intensive care units across the US from 2014 to 2015 based on two different definitions: prior explicit definitions (i.e., based on diagnosis codes) and the Sepsis-3 definitions (i.e., based on SOFA score). The association between intravenous corticosteroids and in-hospital survival up to 50 days in patients with sepsis was retrospectively analyzed. A parametric hazard model with stabilized inverse probability of treatment weight adjustment was used to control for baseline confounders. Of the 7,158 patients identified based on the explicit definition, 562 (7.9%) received corticosteroids; of the 5,009 patients identified based on the Sepsis-3 definition, 465 (9.3%) received corticosteroids. In the explicit cohort, adjusted in-hospital survival at day 50 was 0.62 in the treated vs 0.57 in the non-treated, with a survival difference of 0.05 (95%CI: -0.11, 0.17). Similar results were seen in the Sepsis-3 cohort (0.58 vs 0.56 in treated and non-treated, respectively), with a 50-day survival difference of 0.02 (95%CI: -0.19, 0.17). In patients with sepsis or septic shock, intravenous corticosteroids were not associated with a higher in-hospital survival up to 50 days regardless of the sepsis definitions. Further research may be necessary to definitively confirm effectiveness in real-world practice.