drugset / Trial / NCT03082716

Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery

NCT03082716 ↗

RandomizedParallel-groupTriple-blindOther

Summary

Cardioplegic arrest is an essential part of cardiac surgery which aims to allow myocardial preservation and minimise myocardial swelling ,while providing a motionless and bloodless field ,.Blood cardioplegia has proven its efficacy for several decades and surgeons are still preferring to use it for myocardial protection of paediatric cardiac surgery ,although it is thought to be more time consuming since it is given with interrupted doses, . Even when advancement has came along the field of myocardial protection and cardioplegia solutions with the introduction of Bretschneider Histidine-Tryptophan-Ketoglutarate solution ,custodiol ,in 1970 ,which is given as a single dose and believed to be convenient, simple to deliver , and less time consuming . Many Surgeons haven't change their practice possibly due to paucity of studies comparing cardioplegia solutions in paediatric cardiac surgery and conflicting reports regarding the superiority of different cardioplegia solution.The investigators aim to provide evidence that will help paediatric cardiac surgeons to choose the optimal solution for their practice .

Timeline

Start
2016-03-16
Primary completion
2018-03-29
Completion
2018-03-29

Outcome

Met primary endpoint

paper Custodial cardioplegia is not inferior to blood cardioplegia for myocardial protection in pediatric patients. PMID 37798628 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Custodiol Unknown 400 ml Other
Subject Custodiol Unknown 1000 ml Other