Randomized Controlled Trial on Deep Hypothermic Circulatory Arrest Versus Antegrade Cerebral Perfusion During Neonatal Cardiac Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Heart Defects
- Sponsor
- UMC Utrecht
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan).
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Neonates with a congenital heart defect are often in need of early cardiac surgery. In complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without deep hypothermic circulatory arrest (DHCA). The brain is especially vulnerable to ischemic injury, which puts neonates undergoing complex operations at high risk of neurodevelopmental disorders. Selective antegrade cerebral perfusion (ACP) instead of DHCA during these complex operations may contribute to less cerebral damage, but literature is not conclusive on this issue.
Therefore, the investigators will perform a randomised controlled trial comparing DHCA and ACP in neonatal aortic arch reconstructions, focusing on cerebral damage and neurological outcome.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aortic arch reconstruction (diagnosis of hypoplastic left heart syndrome, hypoplastic aortic arch, severe coarctation and/ or interrupted aortic arch)
- •Infants \<4 months old
Exclusion Criteria
- •Anticipated arch reconstruction time longer than 60 minutes
- •Sedation and intubation especially for the pre-operative MRI-scan of this research project
- •Participation in another clinical trial
- •Failure of data collection
Outcomes
Primary Outcomes
New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan).
Time Frame: Approximately 1 week postoperatively
Secondary Outcomes
- Mortality within 30 days(30 days postoperatively)