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NCT Number: NCT07533994

ACOD1 as a Prognostic Marker for Sepsis

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Blood draw for lab testing.

Other

No clinical or pharmacological intervention.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. In-hospital mortality

    Time frame: Up to 4 weeks after inclusion

    Mortality rate during hospitalization.

  11. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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