ACOD1 as a Prognostic Marker for Sepsis

April 30, 2026 updated by: Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Predictive performance of blood Acod1 gene expression for sepsis mortality
Time Frame: Within 24-48 hours of ICU admission
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Acod1 gene expression detected by RT-qPCR
Time Frame: Within 24-48 hours of ICU admission
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
Time Frame: Within 24-48 hours of ICU admission

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
Time Frame: Within 24-48 hours of ICU admission
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
Time Frame: Within 24-48 hours of ICU admission
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
Time Frame: Within 24-48 hours of ICU admission

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
Time Frame: Within 24-48 hours of ICU admission
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
Time Frame: Within 24-48 hours of ICU admission
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
Time Frame: Within 24-48 hours of ICU admission
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
Time Frame: Within 24-48 hours of ICU admission
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
Time Frame: Up to 4 weeks after inclusion
Mortality rate during hospitalization.
Up to 4 weeks after inclusion
Il1β gene expression in the serum detected by RT-PCR
Time Frame: Within 24-48 hours of ICU admission
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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