NCT07381530

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

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Dr. F. Köhler Chemie GmbH · Industry
• Sex: All
• Age: 24 Hours – 17 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Efficacy of Custodiol-N and its safety is being thoroughly studied in adults undergoing solid organ transplantation. In addition, safety data are available from its use as cardioplegic solution in approximately 400 adults. Paediatric cardiac surgery nearly exclusively addresses congenital heart disease (CHD). CHD comprises a wide variety of congenital malformations of structures of the heart or the great vessels. The causes may be genetic, environmental or both. 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.

Conditions

• Congenital Heart Malformations

Interventions

Type	Name	Description
DRUG	heart will be treated with Custodiol-N	cardioplegia solution will be administered with perfusion
DRUG	heart will be treated with Custodiol	cardioplegia solution will be administered with perfusion

Timeline

• Start date: 2024-12-05
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2026-02-02
• Last updated: 2026-02-09

Locations

3 sites across 1 country: Germany