Study of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children

Summary

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)

Timeline

Start

2024-12-05

Primary completion

2026-12

Completion

2027-12

Outcome

Outcome not reported

Stopped (Business): “Sponsor Decision”

Drugs

Indications