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

NCT ID: NCT00535808

Last Updated: 2012-07-13

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

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Oxygenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Administration of nitroprusside

Group Type EXPERIMENTAL

nitroprusside

Intervention Type DRUG

Administration of nitroprusside

2

Administration of nitroglycerine

Group Type EXPERIMENTAL

nitroglycerine

Intervention Type DRUG

Administration of nitroglycerine

3

Administration of sevoflurane

Group Type EXPERIMENTAL

sevoflurane

Intervention Type DRUG

Administration of Sevoflurane

Interventions

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nitroprusside

Administration of nitroprusside

Intervention Type DRUG

nitroglycerine

Administration of nitroglycerine

Intervention Type DRUG

sevoflurane

Administration of Sevoflurane

Intervention Type DRUG

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annelies Moerman, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2007/270

Identifier Type: -

Identifier Source: org_study_id