SepsisNCT07533994
ACOD1 as a Prognostic Marker for Sepsis
An observational study of Sepsis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- Blood draw for lab testing.
- How many people
- 52 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2025to 6 Feb 2026
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diagnosis of sepsis was established in accordance with the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Critical Care Medicine, Union Hospital, Tongji Medical College,Huazhong University of Science and Technology, Wuhan
Wuhan, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: 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.
- Conditions
- Sepsis
- Being tested
- Blood draw for lab testing.
- Keywords
- Sepsis, Mitochondria, Macrophage
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw for lab testing.Other
No clinical or pharmacological intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24-48 hours of ICU admission
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 24-48 hours of ICU admission
In-hospital mortality
Mortality rate during hospitalization.
Measured: 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.
Measured: Within 24-48 hours of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Oct 2025
- Primary completion6 Feb 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533994
- Sponsor's protocol ID
- 0673
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Acod1 in Prognostic Evaluation of Sepsis: A Prospective, Single-Center, Observational Study
- ClinicalTrials.gov ID
- NCT07533994
- Acronym / sponsor ID
- 0673
- Conditions
- Sepsis
- Keywords
- Sepsis, Mitochondria, Macrophage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of sepsis was established in accordance with the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw for lab testing.No clinical or pharmacological intervention. | Other | – |
Primary outcome
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.
11 secondary outcomes
Blood Acod1 gene expression detected by RT-qPCR
Time frame: 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
Predictive performance of the SOFA score for sepsis mortality
Time frame: 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
Predictive performance of the APACHE II score for sepsis mortality
Time frame: 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
Predictive performance of the blood neutrophils for sepsis mortality
Time frame: 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
Predictive performance of arterial lactate concentration for sepsis mortality
Time frame: Within 24-48 hours of ICU admission
In-hospital mortality
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performance of blood Acod1 gene expression for sepsis mortality (time frame: Within 24-48 hours of ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.