Life sciences · Observational Study
ClinicalTrials.gov · October 7, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07863908). This is a study registration, not published results. Lead sponsor: Shanghai Zhongshan Hospital. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 6000 participants (ESTIMATED). Conditions: Sepsis, ARDS. Interventions: OTHER: Surveys; OTHER: 6-Minute Walk Test; OTHER: Blood collection; DIAGNOSTIC_TEST: Pulmonary & Respiratory Muscle Function Testing; RADIATION: CT Scan; OTHER: Blood Collection; OTHER: Bronchoalveolar Lavage Fluid; OTHER: HME filter samples. Primary outcome measures: All cause mortality , 28-day mortality; EuroQol-5 Dimension-5 Level (EQ-5D-5L) quality of life assessment , 1, 6, 12, 24 month(s). Brief summary: This prospective, multicenter, observational cohort study enrolls 6,000 adults with sepsis and/or acute respiratory distress syndrome (ARDS) at multiple hospitals in China. Clinical data, treatment information, biological samples, and follow-up data are collected to characterize patient features and outcomes and to establish a multicenter clinical cohort and biobank. The study focuses on the clinical and biological heterogeneity of sepsis and ARDS. Longitudinal clinical data are integrated with information on organ function, inflammatory and immune responses, and multi-omics profiles to identify clinically relevant phenotypes and biological subgroups. Biomarkers associated with disease severity, organ dysfunction, treatment response, and mortality are explored, together with models for outcome prediction. Follow-up after hospitalization evaluates long-term survival and recovery, including pulmonary function, physical function, quality of life, and psychological health.