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 (CL-N-CP-Paed-II/09/19)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- The main purpose of the clinical trial is safety assessment regarding • Continuous adverse events (AEs) reporting up to 30 days postoperatively • Myocardial protection in surviving patients, as assessed by quantification of perioperative CK-MB levels (U/l) until day 7 postoperatively (Area under the curve)
研究概览
简要总结
The main purpose of the clinical trial is safety assessment regarding • Continuous adverse events (AEs) reporting up to 30 days postoperatively • Myocardial protection in surviving patients, as assessed by quantification of perioperative CK-MB levels (U/l) until postoperative day 2 and postoperative day 7 or discharge
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
The main purpose of the clinical trial is safety assessment regarding • Continuous adverse events (AEs) reporting up to 30 days postoperatively • Myocardial protection in surviving patients, as assessed by quantification of perioperative CK-MB levels (U/l) until day 7 postoperatively (Area under the curve)
The main purpose of the clinical trial is safety assessment regarding • Continuous adverse events (AEs) reporting up to 30 days postoperatively • Myocardial protection in surviving patients, as assessed by quantification of perioperative CK-MB levels (U/l) until day 7 postoperatively (Area under the curve)
次要结局
- Description of echo
- Description of cardiac injury (incl. creatinine kinase, troponin)
- Hospital/ ICU stay (readmissions, duration)/ Death
- Description of surgery (incl. number of intraoperative administrations of cardioplegia)
- Description of 12-Lead-ECG
- Description of cardiac arrhythmias (incl. need for pacemaker)
- Description of hemodynamics (incl. vitals signs, blood gas parameters, catecholamine support, milrinone support)
研究者
PD Dr. Philippe Grieshaber
Scientific
Dr. Franz Koehler Chemie GmbH