Protection During Cardiac Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 14
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I
研究概览
简要总结
This trial investigates whether a multimodal cardioprotection per-surgery therapeutic strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to traditional management. The primary endpoint is the AUC (area under the curve) of the hypersensitive troponin I. Blood samples will be collected during the 72 hours following the aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Aortic valve surgery (aortic valve replacement associated or not with coronary artery bypass graft, Bentall surgery or Tirone David surgery)
- •Signed informed consent
排除标准
- •Emergency surgery
- •Redo surgery
- •Patient treated with Nicorandil, repaglinid or sulfonylurea 48 hours prior to surgery
- •Low cardiac output requiring catecholamine infusion or circulatory assistance prior to surgery
- •Severe renal failure: dialysis or glomerular filtration rate < 30 mL/min
- •Severe liver failure (spontaneous INR >2)
- •Severe respiratory insufficiency (VEMS <40% of predicted value)
- •Contra-indication to sevoflurane and propofol
- •Myocardial infarction < 7 days
- •Severe upper limb arterial disease
- •Heparin-induced thrombopenia
- •Active infection under antibiotic treatment
- •Any other surgery combined with the aortic valve surgery: myotomia of Morrow (hypertrophic myocardiopathy), treatment of heart rhythm disorder, inter-atrial communication closure, mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement.
- •Pregnant women
- •Currently participating in another trial which may interfere with ProCCard results
- •Not benefiting from a social insurance or similar system
- •Patient under legal protection
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I
时间窗: at 72 hours
Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I determined for each patient with the serial measurement from of troponin I assays.
次要结局
- Length of mechanical ventilation(30 days)
- 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)(Baseline and 30 days)
- Length of stay in intensive care unit (ICU)(30 days)
- Number of participants with catecholaminergic support(baseline and 30 days)
- Dose of catecholaminergic support(baseline and 30 days)
- Adverse events incidence during the first 30 days following surgery of the multimodal cardioprotection strategy(30 days)
- Troponin I serum peak value(72 hours)
- Length of stay in hospital(30 days)
- Troponin I serum value(24 hours)
- Index Gravity Score (IGS II, the scoring system measuring the severity of disease for patients admitted to ICU)(24 hours)
- number of death(30 days)