The Del Nido Cardioplegia Versus the Cold Blood Cardioplegia in Adult Patients Undergoing Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Ventricular fibrillation during reperfusion
研究概览
简要总结
A group of 150 patients undergoing aortic valve replacement procedure will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).
The intraoperative and perioperative outcomes of using each solution will be presented and compared (see the endpoints).
详细描述
The del Nido cardioplegia was developed by Pedro del Nido and his team at the University of Pittsburgh in 1990s. It was primarily designed for children and it has been used in pediatric cardiac surgery in Boston's Children Hospital since 1994.
There are few studies regarding the del Nido cardioplegia. A prospective, randomized trial was designed to determine the efficiency of the del Nido cardioplegia when compared to multidose cold blood cardioplegia in cardiac procedures with short and moderate cross-clamp times.
For the analysis of two cardioprotection protocols, it is essential to compare groups equal in terms of the surgery and perioperative care, with the same surgical risk and cross-clamp time. The research required elimination of all the unnecessary variables.
The patients undergoing aortic valve replacement procedure were selected as a study population. A group of 150 patients will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).
The intraoperative and perioperative outcomes of using each solution will be presented and compared (see the endpoints).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •qualification for isolated aortic valve replacement
- •age>18 years
- •given consent for the study
排除标准
- •reoperation
- •allergy to lidocaine
- •coronary artery disease requiring surgical or percutaneous intervention
- •pregnancy
- •ejection fraction<30%
- •massive aortic calcification ("porcelain aorta")
研究组 & 干预措施
del Nido cardioplegia
干预措施: del Nido cardioplegia (Drug)
cold blood cardioplegia
干预措施: cold blood cardioplegia (Drug)
结局指标
主要结局
Ventricular fibrillation during reperfusion
时间窗: intraoperative
Ventricular fibrillation as first observed rhythm after removing the aortic cross-clamp
hs-TnT (High sensitivity troponin T) - 24 hours
时间窗: 24 hours postoperatively
High sensitivity troponin T measured 24 hours postoperatively
hs-TnT (High sensitivity troponin T) - 48 hours
时间窗: 48 hours postoperatively
High sensitivity troponin T measured 48 hours postoperatively
CK-MB (Creatine kinase- MB isoenzyme) - 24 hours
时间窗: 24 hours postoperatively
Creatine kinase (MB isoenzyme) measured 24 hours postoperatively
CK-MB (Creatine kinase- MB isoenzyme) - 48 hours
时间窗: 48 hours postoperatively
Creatine kinase (MB isoenzyme) measured 48 hours postoperatively
Electrical cardiac activity during cross-clamp
时间窗: intraoperative
Electrical activity observed during the cardiac arrest (cross-clamp)
次要结局
- Overall mortality(30 days postoperative)
- Ventricular fibrillation during the cardioplegia administration(intraoperative)
- Time from the beginning of cardioplegia administration to cardiac arrest(intraoperative)
- Procedural use of the pacemaker(intraoperative)
- Intraoperative myocardial infarction(intraoperative)
- Fall of ejection fraction (EF)(48 hours)
- Inotrope administration(intraoperative, 48 hours)
- Use of the intraaortic balloon pump(intraoperative, 48 hours)
- Perioperative atrial fibrillation(up to 2 weeks)
- Perioperative arrhythmia (other than AF)(up to 2 weeks)
- Postoperative packed red blood cells transfusion(up to 2 weeks)
- Perioperative creatinine values(up to 2 weeks)
- Kidney injury(up to 2 weeks)
- CVVHDF(up to 2 weeks)
- Cardiac death(30 days postoperative)
研究者
Pawel Buszman
Chief Executive Officer
American Heart of Poland