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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
History of Changes

December 15, 2009
June 28, 2012
January 2009
June 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01032876 on ClinicalTrials.gov Archive Site
Mortality within 30 days [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cerebral Perfusion During Neonatal Cardiac Surgery
Randomized Controlled Trial on Deep Hypothermic Circulatory Arrest Versus Antegrade 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Congenital Heart Defects
  • Hypoplastic Left Heart Syndrome
  • Aortic Coarctation
  • 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.
  • Experimental: Deep Hypothermic Circulatory Arrest
    Intervention: Procedure: Deep Hypothermic Circulatory Arrest
  • Experimental: Antegrade Cerebral Perfusion
    Intervention: Procedure: Antegrade Cerebral Perfusion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
up to 4 Months
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01032876
08-090/K
No
Prof. F. Haas, UMC Utrecht
UMC Utrecht
Not Provided
Principal Investigator: Felix Haas, MD UMC Utrecht
UMC Utrecht
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP