Cerebral Perfusion During Neonatal Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT01032876|
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : June 29, 2012
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 or disease||Intervention/treatment||Phase|
|Congenital Heart Defects Hypoplastic Left Heart Syndrome Aortic Coarctation||Procedure: Deep Hypothermic Circulatory Arrest Procedure: Antegrade Cerebral Perfusion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial on Deep Hypothermic Circulatory Arrest Versus Antegrade Cerebral Perfusion During Neonatal Cardiac Surgery|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
|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.
- New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan). [ Time Frame: Approximately 1 week postoperatively ]
- Mortality within 30 days [ Time Frame: 30 days postoperatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032876
|Principal Investigator:||Felix Haas, MD||UMC Utrecht|