Cerebral Perfusion During Neonatal Cardiac Surgery

Congenital Heart Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032876
• Other study ID #: 08-090/K
• Status: Completed
• Phase: N/A
• First received: December 15, 2009
• Last updated: June 28, 2012
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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).
• 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.

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan).		Approximately 1 week postoperatively	Yes
Secondary	Mortality within 30 days		30 days postoperatively	Yes