Levosimendan Versus Milrinone to Support Hemodynamics During Off Pump Coronary Artery Bypass Grafting Surgery in Patients With Poor Ejection Fraction
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean blood pressure
研究概览
简要总结
To compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.
详细描述
The major challenge during off-pump coronary artery bypass graft surgery is to maintain optimum hemodynamics by optimizing the intravascular volume and by using some inotropes. However, conventional inotropes such as beta-agonists are associated with tachycardia and arrhythmia which increase myocardial oxygen demand.
Levosimendan is an inodilator which exerts its positive inotropic effect by enhancing the sensitivity of troponin C to calcium without increasing intracellular calcium concentration. Levosimendan also decreases the systemic vascular resistance, so, it increases the cardiac output without increasing myocardial oxygen consumption.
This study aims to compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective off-pump coronary artery bypass grafting surgery.
- •ejection fraction < 50%
排除标准
- •Patients with severe renal impairment or renal failure.
- •Patients on mechanical support (intra-aortic balloon pump)
研究组 & 干预措施
Levosimendan
Intraoperative infusion of Levosimendan
干预措施: Levosimendan (Drug)
Milrinone
Intraoperative infusion of Milrinone
干预措施: Milrinone (Drug)
结局指标
主要结局
Mean blood pressure
时间窗: Intraoperative
Consumption of other inotropes
时间窗: Intraoperative
次要结局
未报告次要终点
研究者
Hany Mostafa Esmaeil Osman
Principal Investigator
Assiut University