Effects of Diltiazem and/or N-Acétylcystéine Versus Placebo on hémodynamiques and Biological Repercussions of the Ischaemia-réperfusion During the Coronary Surgery With Beating Heart
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine
研究概览
简要总结
Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. The aim of this study was to compare the preventive effects of diltiazem and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump CABG surgery.
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
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age included between 60 and 80 years
排除标准
- •Age < 60 or > 80 years
- •Pregnancy
- •The allergy in used medicines (N-acétylcystéine, Diltiazem)
- •Presence of a pathology valvulaire associated
- •Unstable angor
- •Bypass as a matter of urgency
- •Recours peropératoire to a CEC
- •FE < 0,40
- •BAV of the 2nd and 3rd not sailed degree
- •fibrillation or flutter little finger.
研究组 & 干预措施
Arm1: control group
Received 250 ml of a 5% dextrose solution as placebo drug
干预措施: Placebo (Drug)
Arm 2: diltiazem group
Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
干预措施: Diltiazem (Drug)
Arm 3: acetylcystein group
Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
干预措施: Acetylcystein (Drug)
Arm 4: diltiazem and acetylcystein group
Received a combination of drug :
bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution and 150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution
干预措施: diltiazem and acetylcystein (Drug)
结局指标
主要结局
Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine
时间窗: during ischaemia-reperfusion
Choosing as main biological variable rate cTnI cardiospecific, above the threshold of detection (0.3 mcg / L) in 40% of patients operated on a beating heart hoping to reduce this percentage to 10% as a result of treatment with diltiazem and N-acetylcysteine
次要结局
未报告次要终点