Cerebral Perfusion During Neonatal Cardiac Surgery
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.
|Congenital Heart Defects Hypoplastic Left Heart Syndrome Aortic Coarctation||Procedure: Deep Hypothermic Circulatory Arrest Procedure: Antegrade Cerebral Perfusion|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Randomized Controlled Trial on Deep Hypothermic Circulatory Arrest Versus Antegrade Cerebral Perfusion During Neonatal Cardiac Surgery|
- New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan). [ Time Frame: Approximately 1 week postoperatively ]
- Mortality within 30 days [ Time Frame: 30 days postoperatively ]
|Study Start Date:||January 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Experimental: Deep Hypothermic Circulatory Arrest||
Procedure: Deep Hypothermic Circulatory Arrest
DHCA will be employed for a maximum of 60 minutes. If more time (>60 min) is needed for the arch reconstruction the surgeon will proceed with ACP, which will be continued for the rest of the operation (= DHCA+ACP).
|Experimental: Antegrade Cerebral Perfusion||
Procedure: Antegrade Cerebral Perfusion
One cannula will be advanced into the brachiocephalic/ innominate artery via the usual arterial cannulation site in the aorta ascendens. A flow of 20-25% of the maximum CPB-flow will be used, which corresponds to a flow rate of 40-50 ml/ kg/ min.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032876
|Principal Investigator:||Felix Haas, MD||UMC Utrecht|