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
研究组 & 干预措施
Pringle
The patient will experience Pringle occlusion during the surgery.
Portal vein
The patient will experience and only experience portal vein occlusion during the surgery.
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