ACOD1 as a Prognostic Marker for Sepsis

NCT07533994 | Recruiting DMC

• 1 other identifier: 0673
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Sepsis

Keywords

Sepsis; Mitochondria; Macrophage

Outcome Measures

Primary Outcomes (1)

• Predictive performance of blood Acod1 gene expression for sepsis mortality

  Total RNA was extracted from peripheral blood mononuclear cells (PBMCs) of enrolled patients, reverse-transcribed into cDNA, and Acod1 gene expression quantified by RT-qPCR. The sensitivity and specificity of Acod1 gene expression for predicting sepsis mortality were assessed.

  Within 24-48 hours of ICU admission

Secondary Outcomes (11)

• Blood Acod1 gene expression detected by RT-qPCR

  Within 24-48 hours of ICU admission

• Correlation between blood Acod1 gene expression and SOFA score

  Within 24-48 hours of ICU admission

• Predictive performance of the SOFA score for sepsis mortality

  Within 24-48 hours of ICU admission

• Predictive performance of the blood neutrophil-to-lymphocyte ratio (NLR) for sepsis mortality

  Within 24-48 hours of ICU admission

• Predictive performance of the APACHE II score for sepsis mortality

  Within 24-48 hours of ICU admission

Interventions

Blood draw for lab testing. OTHER

No clinical or pharmacological intervention.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosis of sepsis was established in accordance with the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Department of Critical Care Medicine, Union Hospital, Tongji Medical College,Huazhong University of Science and Technology, Wuhan

Wuhan, Hubei, China

ACTIVE NOT RECRUITING

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

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jiancheng Zhang

CONTACT

13554105815; zhjcheng1@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: April 16, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

CN (2)