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NCT07913464

PF-Organized Corticosteroid-Associated Heterogeneity in Sepsis

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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.

Official title: A Decision-Context-Aligned Multicohort Framework for PF-Organized Corticosteroid-Associated Heterogeneity in Sepsis

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

2693

Start Date

2026-08-05

Completion Date

2026-09-27

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

Systemic Corticosteroids

Systemic corticosteroid exposure occurring as part of routine clinical care. Treatment was not assigned by the investigators. For realized-exposure observational analyses, corticosteroid exposure was defined within 0-72 hours after time zero in the ICCA cohort and within 0-24 hours in the MIMIC and eICU cohorts. Strategy-level analyses evaluated corticosteroid initiation within 24 hours versus no initiation during the corresponding 24-hour strategy window.

Locations (1)

Shanghai Zhongshan hospital

Shanghai, Xuhui, China