Cerebral Perfusion During Neonatal Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01032876
First received: December 15, 2009
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Congenital Heart Defects
Hypoplastic Left Heart Syndrome
Aortic Coarctation
Procedure: Deep Hypothermic Circulatory Arrest
Procedure: Antegrade Cerebral Perfusion

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan). [ Time Frame: Approximately 1 week postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mortality within 30 days [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: January 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01032876

Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Felix Haas, MD UMC Utrecht
  More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. F. Haas, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01032876     History of Changes
Other Study ID Numbers: 08-090/K
Study First Received: December 15, 2009
Last Updated: June 28, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Congenital Heart disease
Cardiopulmonary bypass
Neonatal brain injury
Deep Hypothermic Circulatory Arrest
Antegrade Cerebral Perfusion

Additional relevant MeSH terms:
Aortic Coarctation
Heart Defects, Congenital
Hypoplastic Left Heart Syndrome
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014