RecruitingNCT07533994

ACOD1 as a Prognostic Marker for Sepsis

The Role of Acod1 in Prognostic Evaluation of Sepsis: A Prospective, Single-Center, Observational Study

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

52 participants

Start Date

Oct 1, 2025

Study Type

OBSERVATIONAL

Conditions

Sepsis

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria2

Adult patients aged 18-90 years diagnosed with sepsis according to the Sepsis-3 criteria within 24-48 hours of ICU admission, regardless of sex or ethnicity.
Provision of written informed consent prior to enrollment.

Exclusion Criteria6

Age < 18 years or ≥ 90 years;
Pregnancy or lactation;
Preexisting hematologic malignancy, prior receipt of antineoplastic radiotherapy or chemotherapy, or documented primary immunodeficiency or autoimmune disease;
Receipt of inpatient systemic treatment for sepsis exceeding seven days following initial diagnosis;
Participation in any interventional clinical trial within the preceding three months or concurrent enrollment in another clinical study at the time of screening;
Inability or refusal to provide written informed consent.

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