Randomized Multicentric Trial to Compare Efficacy and Security of Bucberg vs Del Nido Cardioplegic Solutions in Isolated Aortic Valve Replacement.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 286
- 试验地点
- 2
- 主要终点
- CK
研究概览
简要总结
The study compares safety and efficacy of the Del Nido cardioplegic solution, comparing it with the Buckberg cardioplegic solution in single aortic valve replacement procedures. Half the patients will receive the Del Nido solutions while the other half will receive the Buckberg solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Patients older than 18 years old
- •Patients listed for elective aortic valve replacement
- •Patients that have signed informed consent
排除标准
- •Emergent surgery
- •Patients that do not accept blood transfusion
- •Patients with previous cardiac surgery
研究组 & 干预措施
Bukcberg
Buckberg cardioplegical solution administered antegrade and/or retrograde at 1-2ml/Kg for cardiac arrest induction. Arrest manteinance with antegrade and/or retrograde administration at 1-2ml/Kg every 15 to 20 minutes. Reperfusion dose with antegrade or retrograde administration at 15-20 ml/Kg before removing the aortic crossclamp.
干预措施: Buckberg (Drug)
Del Nido
Del Nido cardioplegic solution administered in a single dose at 15-20mg/Kg with a maximum dose of 1L of solution, administered antegrade or retrograde. In those patients in wich the crossclamping time exceed 90 to 120 minutes a manteinance dose of 500ml will be administered.
干预措施: Del Nido (Drug)
结局指标
主要结局
CK
时间窗: 5 days
CK blood levels
Mortality
时间窗: 30 days
All cause mortality
Troponin T
时间窗: 5 days
Troponin T blood levels
次要结局
未报告次要终点