Cardioprotective Effects of Sodium Creatine Phosphate in Valve Surgery: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- serum cardiac troponin I(cTnI)
研究概览
简要总结
To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery
详细描述
Objective
To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery Methods: 250 patients undergoing valve surgery were randomly divided into experimental group and control group. 5g creatine phosphate was dissolved in 50ml saline solution. After induction of anesthesia, the patients were first given a load dose of 1g, 20min (30ml / h) , And then pumped at a rate of 1 g / h (10 ml / h). The control group was treated with saline in the same manner. The cTnI level was measured at the corresponding time points. Hemodynamic indexes and postoperative complications were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass(CPB)
排除标准
- •thoracoscopic valve surgery
- •other organ dysfunction: such as cancer, organ failure, severe anemia, infection
- •patients with mental disorders
- •coagulopathy, active ulcer, ischemic or hemorrhagic stroke (within 6 months), trauma
研究组 & 干预措施
sodium creatine phosphate
5g creatine phosphate was dissolved in 50ml saline solution. After induction of anesthesia, the patients were first given a load dose of 1g, 20min (30ml / h) , And then pumped at a rate of 1 g / h (10 ml / h).
干预措施: sodium creatine phosphate (Drug)
Control
The control group was treated with saline in the same manner.
干预措施: saline (Drug)
结局指标
主要结局
serum cardiac troponin I(cTnI)
时间窗: within 24 hours after aortic declamping
serum cardiac troponin I(cTnI)
次要结局
- mortality(within 30 postoperative days)
- stroke(within 30 postoperative days)
- blood filtration of kidney failure(within 30 postoperative days)
- extracorporeal membrane oxygenation (ECMO) or intraaortic balloon counterpulsation (IABP) support(within 30 postoperative days)
- mechanical ventilation time(within 30 postoperative days)
- arrhythmia(within 30 postoperative days)
研究者
Guyan Wang
The Chief of Infection-Control Department
Chinese Academy of Medical Sciences, Fuwai Hospital