Life sciences · Observational Study
ClinicalTrials.gov · November 3, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07913464). This is a study registration, not published results. Lead sponsor: Shanghai Zhongshan Hospital. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 2693 participants (ACTUAL). Conditions: Sepsis, Critical Illness. Interventions: DRUG: Systemic Corticosteroids. Primary outcome measures: ICU Mortality , From ICU admission (cohort entry) until ICU discharge or death, whichever occurred first, during the index ICU stay. The maximum observed follow-up duration was 90 days.. Brief summary: This retrospective multicohort observational study evaluates whether the PaO2/FiO2 ratio (P/F ratio) organizes heterogeneity in the association between early systemic corticosteroid exposure and mortality among critically ill patients with sepsis. The study uses one internal critical-care cohort (ICCA) and two external critical-care databases (MIMIC and eICU). Analyses include internal discovery, broad external testing, reconstruction of external cohorts toward vasopressor-anchored shock-decision contexts, realized-exposure observational analyses, and strategy-level analyses using a simplified clone-censor-weighting framework (Lite-CCW). The primary objective is to characterize whether corticosteroid-associated outcome patterns differ across P/F strata and whether similar directional patterns are observed across independent ICU datasets after decision-context reconstruction. The study is hypothesis-generating and does not assign corticosteroid treatment or define a clinical treatment-selection rule.