Design and patients
congenital heart disease
We conducted a randomized clinical trial to compare the outcomes of Custodiol cardioplegia (CC) vs. blood cardioplegia (BC) in pediatric cardiac surgery. The study was conducted between January 2018 and January 2021 in King Faisal Specialist Hospital and Research Centre-Jeddah, Saudi Arabia. The data were collected using approved CRFs, and all the data were transferred to REDCap software for management. However, the trial stopped due to COVID-19 and the difficulty of enrollment at the time, and only 487 patients were assessed for eligibility. We included pediatric patients who had a repair on cardiopulmonary bypass and cardioplegia, and neonates were eligible. We excluded adult patients with congenital heart disease, patients who refused to consent (or their guardians), emergency cases, and patients who were lost to follow-up. The study flowchart is presented in Fig. Study flowchart