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Cerebral Perfusion During Neonatal Cardiac Surgery

NCT ID: NCT01032876

Last Updated: 2012-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Defects Hypoplastic Left Heart Syndrome Aortic Coarctation

Keywords

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Congenital Heart disease Cardiopulmonary bypass Neonatal brain injury Deep Hypothermic Circulatory Arrest Antegrade Cerebral Perfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Deep Hypothermic Circulatory Arrest

Group Type EXPERIMENTAL

Deep Hypothermic Circulatory Arrest

Intervention Type 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

Group Type EXPERIMENTAL

Antegrade Cerebral Perfusion

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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UMC Utrecht

Principal Investigators

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Felix Haas, MD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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UMC Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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Algra SO, Jansen NJ, van der Tweel I, Schouten AN, Groenendaal F, Toet M, van Oeveren W, van Haastert IC, Schoof PH, de Vries LS, Haas F. Neurological injury after neonatal cardiac surgery: a randomized, controlled trial of 2 perfusion techniques. Circulation. 2014 Jan 14;129(2):224-33. doi: 10.1161/CIRCULATIONAHA.113.003312. Epub 2013 Oct 20.

Reference Type DERIVED
PMID: 24141323 (View on PubMed)

Algra SO, Groeneveld KM, Schadenberg AW, Haas F, Evens FC, Meerding J, Koenderman L, Jansen NJ, Prakken BJ. Cerebral ischemia initiates an immediate innate immune response in neonates during cardiac surgery. J Neuroinflammation. 2013 Feb 7;10:24. doi: 10.1186/1742-2094-10-24.

Reference Type DERIVED
PMID: 23390999 (View on PubMed)

Algra SO, Schouten AN, van Oeveren W, van der Tweel I, Schoof PH, Jansen NJ, Haas F. Low-flow antegrade cerebral perfusion attenuates early renal and intestinal injury during neonatal aortic arch reconstruction. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1323-8, 1328.e1-2. doi: 10.1016/j.jtcvs.2012.03.008. Epub 2012 Apr 13.

Reference Type DERIVED
PMID: 22503201 (View on PubMed)

Other Identifiers

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08-090/K

Identifier Type: -

Identifier Source: org_study_id