Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery with Extracorporeal Circulation. CARDIO-HEART Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Comparison of the composite event
研究概览
简要总结
Phase IV clinical trial of a single-blind, prospective and longitudinal randomized intervention comparing patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia.
详细描述
Myocardial protection by administering cardioplegia is a fundamental concept during cardiopulmonary bypass in patients undergoing cardiac surgery. It is a multifactorial strategy, in which cardioplegia is the most important. To date, there is no standardized consensus on the use of cardioplegia in different cardiac surgery procedures, and the best strategy continues to be debated given the wide range available. The choice of the type of cardioplegia should be made on an individual basis, taking into account the surgical procedure and clinical context. The need for a single dose of cardioplegia could favor the use of Custodiol crystaloid cardioplegia in complex cardiac surgeries that require longer extracorporeal circulation time. Both cardioplegia are safe and effective and widely used globally; however, the information provided in the literature is limited, with most of the information coming from retrospective studies.The objective of the present study is to demonstrate the non-inferiority of Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia in patients undergoing major cardiac surgery with extracorporeal circulation with prolonged aortic clamping times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
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 over 18 years of age.
- •Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.
排除标准
- •Aortic arch procedures.
- •Procedures in which hypothermia <28ºC is expected during the intervention.
- •Minimally invasive procedures "Port Access".
- •Active endocarditis.
- •Emerging procedures.
- •Isolated aortic valve replacements.
- •Decision of the main surgeon not to participate in the study due to other clinical criteria.
研究组 & 干预措施
Buckberg
Patients who will be administered Buckberg blood cardioplegia.
干预措施: Buckberg Cardi-Braun (Drug)
Custodiol
Patients who will be administered Custodiol crystalloid cardioplegia.
干预措施: Custodiol Htk Soln (Drug)
结局指标
主要结局
Comparison of the composite event
时间窗: 90 days after the intervention
Comparison of the composite event of death, perioperative AMI, low cardiac postoperative output with need for ionotropics, and AKIN-III acute kidney failure
次要结局
- Differences in the incidence of elevation of Troponin(90 days after the intervention)
- Differences in the 90-day mortality rate(90 days after the intervention)
- Differences in the incidence of low cardiac postoperative output(90 days after the intervention)
- Differences in the incidence of acute kidney failure event(90 days after the intervention)
- Differences in the incidence of acute myocardial infarction(90 days after the intervention)
- Differences in the incidence of major bleeding event(90 days after the intervention)
- Differences in the incidence of the need of transfusion(90 days after the intervention)
- Differences in the incidence of prolonged mechanical ventilation(90 days after the intervention)
- Differences in the incidence of neurological complications(90 days after the intervention)
- Differences in the incidence of postoperative atrial fibrillation.(90 days after the intervention)
- Differences in the overall survival rate at 90 days.(90 days after the intervention)
研究者
Lourdes Montero Cruces
Principal Investigator
Hospital San Carlos, Madrid