Clinical Trial

ACOD1 as a Prognostic Marker for Sepsis

Completed
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Summary
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, with high morbidity and mortality worldwide. Reliable biomarkers are needed for early risk stratification and outcome prediction. This prospective, single-center, observational study aims to evaluate the prognostic value of Acod1 gene expression in peripheral blood mononuclear cells (PBMCs) from septic patients. The primary objective is to assess the sensitivity and specificity of ACOD1 expression measured by RT-qPCR within 24-48 hours of ICU admission for predicting sepsis mortality. Secondary objectives include correlating ACOD1 expression with the SOFA score, and comparing its predictive performance against established clinical markers and scores such as APACHE II, SOFA, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), arterial lactate, and IL-1β expression. The study will also report in-hospital mortality. Findings may support ACOD1 as a novel molecular biomarker for early prognostic assessment in sepsis.
Protocol Amendment History 3 changes
critical Trial completed 2026-05-02
notable Primary completion moved earlier: 2026-06-01 -> 2026-02-06 2026-05-02
minor Completion moved earlier: 2026-06-01 -> 2026-02-06 2026-05-02
Trial Details
NCT Number NCT07533994
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Sepsis
Enrollment 52 participants
Start Date 2025-10-01
Primary Completion 2026-02-06 (estimated)
Study Completion 2026-02-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-01