Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: A Randomized Study

Cerebral Oxygenation Clinical Trial

Official title:

Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535808
• Other study ID #: 2007/270
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2007
• Last updated: July 12, 2012
• Start date: October 2007
• Est. completion date: March 2011

Study information

• Verified date: July 2012
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

In a prospective and randomized study protocol, three different blood pressure regulating agents (nitroprusside, nitroglycerine, sevoflurane) will be compared concerning their effect on the cerebral oxygen balance between both hemispheres during aortic coarctation repair. Cerebral and somatic saturation will be monitored non-invasively and continuously via optical sensors applied to the right and left forehead and the somatic regions. Arterial blood pressure, central venous pressure, heart rate and systemic saturation will be recorded continuously. Intermittently, arterial and venous blood gas analysis will be performed at 6 definite time intervals. The study ends at the end of the operation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• All neonates and infants

• Aged 0-18 year

• With aortic coarctation requiring surgical correction without the additional use of cardiopulmonary bypass will be included.

Exclusion Criteria:

• All patients with an associated cardiac effect are excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Coarctation
• Cerebral Oxygenation

Intervention

Drug:
• nitroprusside
Administration of nitroprusside
• nitroglycerine
Administration of nitroglycerine
• sevoflurane
Administration of Sevoflurane

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral saturation		During operation	Yes

External Links

•   Website of the University Hospital Ghent