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OpenTrials
Completed

NCT Number: NCT01032876

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.

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Key information

Conditions

Congenital Heart Defects Aortic Coarctation Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hypoplastic Left Heart Syndrome

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Utrecht

Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Hypothermic Circulatory Arrest

Procedure

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

Procedure

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.

Primary outcomes

  1. New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan).

    Time frame: Approximately 1 week postoperatively

Secondary outcomes

  1. Mortality within 30 days

    Time frame: 30 days postoperatively

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 16, 2009
Registry last updated
Jun 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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