PRO-TECT II: Propofol Cardioprotection for Type II Diabetics
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Perioperative Plasma 15 f2t isoprostane, a biologically active marker of oxidative stress
研究概览
简要总结
The purpose of this study is to determine if an intravenous anesthetic with antioxidant properties will protect the heart of diabetic patients from injury while undergoing coronary bypass surgery.
详细描述
Diabetic patients are at elevated risk for low cardiac output syndrome. This high risk scenario adversely affects up to 26% of patients recovering from cardiac surgery. Aggressive hemodynamic treatments are required, but can prove inadequate. Low cardiac output syndrome can quadruple the overall mortality rate for aortocoronary bypass surgery from 2% to 8%. Therefore, an urgent need exists for effective forms of preemptive cardioprotection and antioxidant protection may play a crucial role. Our research into the therapeutic potential of propofol, an intravenous anesthetic with antioxidant properties, could have significant impact on outcome in this select population. The proposed study represents a novel therapeutic approach for the prevention of myocardial ischemia-reperfusion injury in diabetic patients undergoing cardiac surgery with cardiopulmonary bypass.
RESEARCH PLAN
Two blinded, randomized controlled phase II studies will be conducted in patients undergoing primary aortocoronary bypass surgery.
STUDY A
Specific Aims:
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 (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with and without Type II Diabetes Mellitus
- •Hemodynamically Stable
- •Non urgent Coronary Bypass Grafting utilizing Cardiopulmonary Bypass
排除标准
- •Age less than 18 or greater than 80 years of age
- •refuse informed consent
- •Co-existing valvular heart disease
- •Acute or evolving myocardial infarction
- •hypersensitivity to propofol or formulation component
- •Use of NSAIDs, Vitamins C or E within 5 to 7 days of surgery
研究组 & 干预措施
1
Propofol Cardioprotection
干预措施: Propofol (Drug)
2
Volatile Anesthesia Preconditioning
干预措施: Propofol (Drug)
结局指标
主要结局
Perioperative Plasma 15 f2t isoprostane, a biologically active marker of oxidative stress
时间窗: 24 hours post operation
次要结局
- Perioperative (includes coronary sinus levels) plasma antioxidant concentration; ET-1, TNF alpha, Troponin I, peroxynitrite; gene and protein expression of eNOS and iNOS; hemodynamics(24 hours post operation)