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ACOD1 Gene Expression as Sepsis Mortality Predictor

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Summary

NIH has registered a new observational clinical study (NCT07533994) on ClinicalTrials.gov evaluating ACOD1 gene expression in peripheral blood mononuclear cells as a prognostic biomarker for predicting sepsis mortality. The single-center study will enroll septic ICU patients and correlate ACOD1 expression with clinical severity scores and in-hospital mortality outcomes.

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What changed

NIH has registered a new prospective, single-center, observational study on ClinicalTrials.gov titled 'ACOD1 as a Prognostic Marker for Sepsis.' The study will evaluate ACOD1 gene expression measured by RT-qPCR in peripheral blood mononuclear cells within 24-48 hours of ICU admission for predicting sepsis mortality, correlating findings with SOFA, APACHE II, CRP, lactate, and other clinical markers.

This registry entry does not create compliance obligations for external parties. Clinical investigators, research hospitals, and academic medical centers conducting similar biomarker or sepsis research may reference this study for context on emerging prognostic marker evaluation methodologies. The study is registered under GxP-compliant ClinicalTrials.gov procedures.

Archived snapshot

Apr 16, 2026

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ACOD1 as a Prognostic Marker for Sepsis

Observational NCT07533994 Kind: OBSERVATIONAL Apr 16, 2026

Abstract

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.

Conditions: Sepsis

Interventions: Blood draw for lab testing.

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07533994
Docket
NCT07533994

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Biomarker research Clinical trial registration Gene expression testing
Geographic scope
United States US

Taxonomy

Primary area
Public Health
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Pharmaceuticals

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