Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Incidence of Low Cardiac Output Syndrome
研究概览
简要总结
Open-heart surgery causes injury of the heart muscle. Although this is usually mild, temporary and reversible, if it is severe it can endanger life and require additional high cost care. During surgery, techniques are used to protect the heart from injury, but these remain imperfect. This study assesses the effect of facilitating sugar metabolism (a more efficient fuel) by the heart muscle using the drug Perhexiline given before the operation. This treatment has a sound experimental basis for improving outcome. If this improvement is confirmed surgical results could be improved. The investigators will be studying heart function, heart muscle energy stores and chemicals which quantify the amount of heart muscle injury. The investigators' hypothesis is that Perhexiline will improve the protection of the heart by decreasing damage that may occur during heart 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •First-time
- •Isolated coronary artery bypass surgery
排除标准
- •Diabetes Mellitus
- •Renal impairment with Creatinine greater than or equal to 200micromol/L
- •Atrial fibrillation
- •Amiodarone therapy, recent (in last month) or current
- •Hepatic impairment, significant preoperative
- •Peripheral neuropathy
- •Pregnancy or breast-feeding
- •Emergency surgery or required on clinical grounds within 5 days of referral
研究组 & 干预措施
Perhexiline
Pre-operative administration of Perhexiline tablets according to dosing schedule
干预措施: Perhexiline (Drug)
Placebo
Pre-operative administration of placebo tablets according to dosing schedule
干预措施: Placebo marked PEXSIG (Drug)
结局指标
主要结局
Incidence of Low Cardiac Output Syndrome
时间窗: 6 hours post-removal of aortic X-clamp
次要结局
- Increase in Cardiac index of greater than or equal to 0.3 L/min/m2(6 hours post-removal of aortic X-clamp)
- Incidence of inotropes use according to protocol(6 and 12 hours post-removal of aortic X-clamp)
- Peak and total release of Troponin(6, 12 and 24 hours post-release of aortic X-clamp)