NCT00188994Unknown不适用
Insulin Cardioplegia Trial for Poor Left Ventricular Function
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Low Output Syndrome
研究概览
简要总结
The purpose of this investigation is to develop a means to improve the recovery of cardiac metabolism and ventricular function following coronary artery bypass surgery (CABG) in patients with poor preoperative ventricular function (e.g. ejection fraction <40%).
详细描述
Hypothesis
Insulin added to blood cardioplegia will improve the results of Coronary Artery Bypass Graft by reducing the incidence of low output syndrome (i.e., the requirement for inotropic or balloon pump assistance) in patients with a preoperative ejection fraction <40%.
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
- Double
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been referred for isolated coronary bypass surgery.
- •LV grade 3 or 4, LVEF <40% by angio, echo, RNA.
排除标准
- •Patient is undergoing reoperative surgery (i.e., has had any previous cardiac surgery)
- •Surgeon has planned another procedure in addition to coronary bypass surgery (e.g., valve repair, replacement, ascending aorta repair or replacement, left ventricular aneurysm resection, repair of congenital defect, carotid surgery, repair of abdominal aortic aneurysm).
- •Patient is scheduled for minimally invasive surgery.
- •More recent assessment of LV function with LV grade 1 0r 2, LVEF>40%.
- •5 or 6 days post MI.
结局指标
主要结局
Low Output Syndrome
次要结局
- Total Troponin I Release
研究者
研究点 (2)
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