Cardiopulmonary Bypass Ischemia/Reperfusion Injury and Postoperative Multiple Organ Dysfunction in Elder Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- incidence of postoperative cardiac injury
研究概览
简要总结
The aim of the study is to identify the correlation between ischaemia reperfusion injury and postoperative multiorgan damage during cardiopulmonary cardiac surgery; and to investigate biomarkers that can predict postoperative organ damage in cardiac surgery.
详细描述
This study proposes to observe multi-organ functional impairment of the heart, kidney and brain after extracorporeal circulation in a prospective study of clinical patients; to obtain markers with diagnostic and predictive efficacy by collecting pre and postoperative serum and heart and ear tissue samples from patients with postoperative organ functional impairment, performing combined proteomic and metabolomic analyses, and by analysing them with detailed postoperative clinical prognostic data using machine learning algorithms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years; patients requiring mitral valve replacement surgery or mitral valve plus aortic valve replacement under cardiopulmonary bypass
- •Agreed to participate in this study, and signed the informed consent form.
排除标准
- •History of neurological disease (stroke, reversible ischemic hypoxia, transient ischemic attack, or Neurodegeneration) ;
- •Patients with severe preoperative renal insufficiency (serum creatinine > 442 μmol/L or need renal replacement therapy) ,
- •liver dysfunction (Child-Pugh grade C)
- •myocardial infarction within 4 weeks
- •ASA grade ≥ V
结局指标
主要结局
incidence of postoperative cardiac injury
时间窗: from the ending of surgery to 7 days after surgery
troponin I will be tested before and after surgery
incidence of postoperative brain injury
时间窗: from the ending of surgery to 7 days after surgery
deliriumwill be tested before and after surgery
incidence of postoperative acute kidney injury
时间窗: from the ending of surgery to 7 days after surgery
renal function will be tested before and after surgery
次要结局
- Incidence of postoperative arrhythmia events(from the ending of surgery to 72 hours after surgery)