The Role of Acod1 in Prognostic Evaluation of Sepsis: A Prospective, Single-Center, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Predictive performance of blood Acod1 gene expression for sepsis mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Predictive performance of blood Acod1 gene expression for sepsis mortality
时间窗: 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.
次要结局
- Blood Acod1 gene expression detected by RT-qPCR(Within 24-48 hours of ICU admission)
- Correlation between blood Acod1 gene expression and SOFA score(Within 24-48 hours of ICU admission)
- Predictive performance of the SOFA score for sepsis mortality(Within 24-48 hours of ICU admission)
- Predictive performance of the blood neutrophil-to-lymphocyte ratio (NLR) for sepsis mortality(Within 24-48 hours of ICU admission)
- Predictive performance of the APACHE II score for sepsis mortality(Within 24-48 hours of ICU admission)
- Predictive performance of the blood platelet-to-lymphocyte ratio (PLR) for sepsis mortality(Within 24-48 hours of ICU admission)
- Predictive performance of the blood neutrophils for sepsis mortality(Within 24-48 hours of ICU admission)
- Predictive performance of the blood CRP for sepsis mortality(Within 24-48 hours of ICU admission)
- Predictive performance of arterial lactate concentration for sepsis mortality(Within 24-48 hours of ICU admission)
- In-hospital mortality(Up to 4 weeks after inclusion)
- Il1β gene expression in the serum detected by RT-PCR(Within 24-48 hours of ICU admission)
研究者
Jiancheng Zhang
Dr.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology