Cardiothoracic Surgery Department, King Faisal Specialist Hospital and Research Centre,, MBC J-16, P.O. Box: 40047, 21499, Jeddah, Saudi Arabia.
Cardiothoracic Surgery Department, Tanta University, Tanta, Egypt.
Eur J Med Res. 2023 Oct 5;28(1):404. doi: 10.1186/s40001-023-01372-4.
Blood-based cardioplegia is the standard myocardial protection strategy in pediatric cardiac surgery. Custadiol (histidine-tryptophan-ketoglutarate), an alternative, may have some advantages but is potentially less effective at myocardial protection. This study aimed to test whether custadiol is not inferior to blood-based cardioplegia in pediatric cardiac surgery.
The study was designed as a randomized controlled trial with a blinded outcome assessment. All pediatric patients undergoing cardiac surgery with cardiopulmonary bypass and cardioplegia, including neonates, were eligible. Emergency surgery was excluded. The primary outcome was a composite of death within 30 days, an ICU stay longer than 5 days, or arrhythmia requiring intervention. Secondary endpoints included total hospital stay, inotropic score, cardiac troponin levels, ventricular function, and extended survival postdischarge. The sample size was determined a priori for a noninferiority design with an expected primary outcome of 40% and a clinical significance difference of 20%.
Between January 2018 and January 2021, 226 patients, divided into the Custodiol cardioplegia (CC) group (n = 107) and the blood cardioplegia (BC) group (n = 119), completed the study protocol. There was no difference in the composite endpoint between the CC and BC groups, 65 (60.75%) vs. 71 (59.66%), respectively (P = 0.87). The total length of stay in the hospital was 14 (Q2-Q3: 10-19) days in the CC group vs. 13 (10-21) days in the BC group (P = 0.85). The inotropic score was not significantly different between the CC and BC groups, 5 (2.6-7.45) vs. 5 (2.6-7.5), respectively (P = 0.82). The cardiac troponin level and ventricular function did not differ significantly between the two groups (P = 0.34 and P = 0.85, respectively). The median duration of follow-up was 32.75 (Q2-Q3: 18.73-41.53) months, and there was no difference in survival between the two groups (log-rank P = 0.55).
Custodial cardioplegia is not inferior to blood cardioplegia for myocardial protection in pediatric patients. Trial registration The trial was registered in Clinicaltrials.gov, and the ClinicalTrials.gov Identifier number is NCT03082716 Date: 17/03/2017.
血基心脏停搏液是儿科心脏手术中标准的心肌保护策略。Custadiol（组氨酸-色氨酸-酮戊二酸）是一种替代方案，可能具有一些优势，但在心肌保护方面效果可能较差。本研究旨在测试 Custadiol 是否在儿科心脏手术中不比血基心脏停搏液差。
该研究设计为一项随机对照试验，采用盲法结局评估。所有接受体外循环和心脏停搏液的儿科心脏手术患者，包括新生儿，均符合条件。排除急诊手术。主要结局是 30 天内死亡、重症监护病房住院时间超过 5 天或需要干预的心律失常的复合结局。次要终点包括总住院时间、正性肌力评分、心脏肌钙蛋白水平、心室功能和出院后延长生存时间。根据预期主要结局为 40%和临床差异为 20%的非劣效性设计预先确定了样本量。
2018 年 1 月至 2021 年 1 月，226 名患者分为 Custodiol 心脏停搏液（CC）组（n=107）和血心脏停搏液（BC）组（n=119）完成了研究方案。CC 组和 BC 组之间的复合终点无差异，分别为 65（60.75%）和 71（59.66%）（P=0.87）。CC 组的总住院时间为 14 天（Q2-Q3：10-19），BC 组为 13 天（Q2-Q3：10-21）（P=0.85）。CC 组和 BC 组的正性肌力评分无显著差异，分别为 5（2.6-7.45）和 5（2.6-7.5）（P=0.82）。两组的心脏肌钙蛋白水平和心室功能无显著差异（P=0.34 和 P=0.85）。中位随访时间为 32.75 个月（Q2-Q3：18.73-41.53），两组生存率无差异（对数秩 P=0.55）。
Custodial 心脏停搏液在儿科患者中的心肌保护效果并不逊于血基心脏停搏液。
该试验在 ClinicalTrials.gov 上注册，ClinicalTrials.gov 标识符为 NCT03082716，日期：2017 年 3 月 17 日。
