NCT01032876

Cerebral Perfusion During Neonatal Cardiac Surgery

Randomized Controlled Trial on Deep Hypothermic Circulatory Arrest Versus Antegrade Cerebral Perfusion During Neonatal Cardiac Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 4 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Defects
• Hypoplastic Left Heart Syndrome
• Aortic Coarctation

Interventions

Type	Name	Description
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).
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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-12-16
• Last updated: 2012-06-29

Locations

1 site across 1 country: Netherlands