ACOD1 as a Prognostic Marker for Sepsis

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: Blood draw for lab testing.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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).

Description

Inclusion Criteria:

1. 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.
2. Provision of written informed consent prior to enrollment.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Acod1 gene expression detected by RT-qPCR	Total RNA was extracted from PBMCs isolated from enrolled patients, reverse-transcribed into cDNA, and Acod1 expression quantified by RT-qPCR.	Within 24-48 hours of ICU admission
Correlation between blood Acod1 gene expression and SOFA score	Correlation analysis between Acod1 gene expression in PBMCs and Sequential Organ Failure Assessment (SOFA) score. The SOFA score is a tool used in intensive care to track the severity of organ dysfunction in six systems (respiratory, coagulation, liver, cardiovascular, central nervous system, and renal). Each system is scored from 0 (normal) to 4 (most severe), giving a total between 0 and 24. A rise of 2 points or more from baseline helps define sepsis, and higher scores correlate with increased mortality risk.	Within 24-48 hours of ICU admission
Predictive performance of the SOFA score for sepsis mortality	After enrollment, patient data collected on the same day as RT-qPCR testing, including SOFA score, were analyzed to assess the sensitivity and specificity of the SOFA score for predicting sepsis mortality.	Within 24-48 hours of ICU admission
Predictive performance of the blood neutrophil-to-lymphocyte ratio (NLR) for sepsis mortality	After enrollment, patient data collected on the same day as RT-qPCR testing, including the absolute number of neutrophils and lymphocytes, were analyzed to assess the sensitivity and specificity of the NLR for predicting sepsis mortality.	Within 24-48 hours of ICU admission
Predictive performance of the APACHE II score for sepsis mortality	After enrollment, the sensitivity and specificity of the Acute Physiology and Chronic Health Evaluation II (APACHE II) score for predicting sepsis mortality were assessed. The APACHE II scoring system comprises three components: the Acute Physiology Score (APS), an age score, and a chronic health score. The total score is the sum of these three components, with a theoretical maximum of 71 points-higher scores indicate more severe disease. The APS incorporates 12 physiological parameters and provides a formula to calculate the risk of death (R). The expected mortality rate for a cohort is derived by summing the R values of all patients and dividing by the total number of patients. Currently, APACHE II serves as a primary assessment tool for patients admitted to the ICU.	Within 24-48 hours of ICU admission
Predictive performance of the blood platelet-to-lymphocyte ratio (PLR) for sepsis mortality	After enrollment, patient data collected on the same day as PCR testing, including the absolute number of platelets and lymphocytes, were analyzed to assess the sensitivity and specificity of the PLR for predicting sepsis mortality.	Within 24-48 hours of ICU admission
Predictive performance of the blood neutrophils for sepsis mortality	After enrollment, patient data collected on the same day as RT-qPCR testing, including the absolute number of neutrophils, were analyzed to assess the sensitivity and specificity of the NLR score for predicting sepsis mortality.	Within 24-48 hours of ICU admission
Predictive performance of the blood CRP for sepsis mortality	After enrollment, patient data collected on the same day as RT-qPCR testing, including the serum level of C-reactive protein (CRP), were analyzed to assess the sensitivity and specificity of the NLR score for predicting sepsis mortality.	Within 24-48 hours of ICU admission
Predictive performance of arterial lactate concentration for sepsis mortality	After enrollment, patient data collected on the same day as RT-qPCR testing, including the level of arterial lactate, were analyzed to assess the sensitivity and specificity of the NLR score for predicting sepsis mortality.	Within 24-48 hours of ICU admission
In-hospital mortality	Mortality rate during hospitalization.	Up to 4 weeks after inclusion
Il1β gene expression in the serum detected by RT-PCR	Total RNA was extracted from PBMCs isolated from enrolled patients, reverse-transcribed into cDNA, and Il1β expression quantified by RT-qPCR.	Within 24-48 hours of ICU admission

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): February 6, 2026
• Study Completion (Actual): February 6, 2026

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Sepsis; Mitochondria; Macrophage
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 0673 (Universitätsklinikum Erlangen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No