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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw for lab testing. | Other | No clinical or pharmacological intervention. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Diagnosis of sepsis was established in accordance with the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Critical Care Medicine, Union Hospital, Tongji Medical College,Huazhong University of Science and Technology, Wuhan | Wuhan | Hubei | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Sep 18, 2024 | Feb 15, 2026 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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 |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |