Differential Impact of Pringle Occlusion vs. Portal Vein Occlusion-Induced Liver Ischaemia-Reperfusion Injury on Myocardial Injury Following Noncardiac Surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,286
- 试验地点
- 2
- 主要终点
- Myocardial injury after non-cardiac surgery (MINS)
研究概览
简要总结
This study aims to investigate the impact of hepatic ischemia-reperfusion injury (HIRI) on the incidence of myocardial injury after non-cardiac surgery (MINS) and explore the potential underlying mechanisms. A bidirectional cohort study will be conducted, enrolling patients scheduled for major hepato-biliary surgery. Clinical data, perioperative parameters, and postoperative follow-up data will be systematically collected. The incidence of MINS between patients undergoing Pringle occlusion and portal vein occlusion will be compared, and a multivariate analysis will be performed to identify independent risk factors for MINS, providing a basis for early recognition and prevention of MINS.
详细描述
This observational cohort study consists of both retrospective and prospective components. The study population includes patients undergoing major hepato-biliary surgery (defined as operative time > 4 hours and postoperative ICU admission) who are either ≥ 65 years old or ≥ 45 years old with cardiovascular risk factors (especially known cardiovascular disease). The exposed group (Pringle group) consists of patients who experience liver ischemia-reperfusion injury due to Pringle occlusion during surgery. The control group (Portal vein group) consists of patients who experience liver ischemia-reperfusion injury due to Portal vein occlusion. The primary outcome is the incidence of MINS (myocardial injury after non-cardiac surgery) within 3 days postoperatively. Secondary outcomes include postoperative length of hospital stay, incidence of complications within 30 days postoperatively, and 1-year survival rate. Finally, liver and blood samples will be collected from a subset of patients in the prospective LIRI group for pathophysiological mechanism investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years, or ≥ 45 years with cardiovascular risk factors (especially known cardiovascular disease).
- •Undergoing elective major hepatopancreatobiliary surgery under general anesthesia.
- •ASA physical status II-III.
- •Provide written informed consent to participate in the study (applicable to the prospective cohort).
排除标准
- •Emergency surgery
- •Preoperative diagnosis of myocardial infarction or unstable angina
- •Severe hepatic insufficiency (Child-Pugh class C)
- •Concomitant severe organ dysfunction (e.g., renal failure, respiratory failure)
- •Concomitant active infectious disease
结局指标
主要结局
Myocardial injury after non-cardiac surgery (MINS)
时间窗: Within 3 days after surgery
MINS, a high-sensitivity troponin T (hs-cTnT) of 20 to \<65 ng/L with an absolute change of at least 5 ng/L
次要结局
未报告次要终点
研究者
Zhifeng Gao
Associate Professor
Beijing Tsinghua Chang Gung Hospital