A Prospective Randomized, Single-blind, Multicenter Phase II Study Comparing Two Methods of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children: Custodiol-N Versus Custodiol
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- safety assessment
研究概览
简要总结
The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation. All endpoint timings refer to the opening of the aortic cross clamp (t=0)
详细描述
Efficacy of Custodiol-N and its safety is being thoroughly studied in adults undergoing solid organ transplantation. In addition, safety data are available from its use as cardioplegic solution in approximately 400 adults. Paediatric cardiac surgery nearly exclusively addresses congenital heart disease (CHD). CHD comprises a wide variety of congenital malformations of structures of the heart or the great vessels. The causes may be genetic, environmental or both. The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation.
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)
盲法说明
The patient and their legal representatives will be blinded to treatment. All other parties are unblinded.
入排标准
- 年龄范围
- 24 Hours 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from birth to less than 18 years of age
- •congenital heart surgery with cardiopulmonary bypass and cardioplegia
- •written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study)
- •Ability of the legal guardians to understand character and individual consequences of the clinical trial
排除标准
- •Patients who have participated within 30 days or are still participating in any other interventional study
- •History of severe organic (e.g. liver or kidney) disease other than concerning the heart
- •History of psychiatric disease
- •Pregnancy and lactation
研究组 & 干预措施
Custodiol-N
organ will be perfused with Custodiol-N solution
干预措施: heart will be treated with Custodiol-N (Drug)
Custodiol
organ will be perfused with Custodiol solution
干预措施: heart will be treated with Custodiol (Drug)
结局指标
主要结局
safety assessment
时间窗: AEs up to 30 days postoperatively
Continuous adverse events (AEs) reporting
safety assessment
时间窗: CK-MB (Creatinkinase-MB) levels at baseline until postoperative day 2 and postoperative day 7 or discharge
Myocardial protection in surviving patients assessed by quantification of perioperative CK-MB levels (U/l)
次要结局
- Description of hemodynamics(day 7 postoperatively)
- Description of hemodynamics(30 days postoperatively)
- Description of echo(Baseline, after skin closure and day 7 postoperatively)
- Description of cardiac injury(at baseline until postoperative day 2 and postoperative day 7 or discharge)
- Description of hospitals stay/ death(30 days postoperatively)
- Description of surgery(during surgery)
- Description of 12-Lead-ECG(baseline and day 1 postoperatively (Intensive Care Unit))
- Description of cardiac arrhythmias(until day 7 postoperatively)
- Description of cardiac arrhythmias(30 days postoperatively)