Aortic Coarctation, Congenital Heart Defects, Hypoplastic Left Heart Syndrome
Conditions
Keywords
Congenital Heart disease, Cardiopulmonary bypass, Neonatal brain injury, Deep Hypothermic Circulatory Arrest, Antegrade Cerebral Perfusion
Brief 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.
Interventions
PROCEDUREDeep 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).
PROCEDUREAntegrade 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.
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan). | Approximately 1 week postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Mortality within 30 days | 30 days postoperatively |
Countries
Netherlands
Outcome results
None listed