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

Primary Purpose

Cerebral Oxygenation

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

nitroprusside

nitroglycerine

sevoflurane

About this trial

This is an interventional treatment trial for Cerebral Oxygenation

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

Administration of nitroprusside

Administration of nitroglycerine

Administration of sevoflurane

Outcomes

Primary Outcome Measures

Cerebral saturation

Secondary Outcome Measures

Full Information

NCT ID

NCT00535808

First Posted

September 25, 2007

Last Updated

July 12, 2012

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT00535808

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Oxygenation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Administration of nitroprusside

Arm Title

Arm Type

Experimental

Arm Description

Administration of nitroglycerine

Arm Title

Arm Type

Experimental

Arm Description

Administration of sevoflurane

Intervention Type

Drug

Intervention Name(s)

nitroprusside

Intervention Description

Administration of nitroprusside

Intervention Type

Drug

Intervention Name(s)

nitroglycerine

Intervention Description

Administration of nitroglycerine

Intervention Type

Drug

Intervention Name(s)

sevoflurane

Intervention Description

Administration of Sevoflurane

Primary Outcome Measure Information:

Title

Cerebral saturation

Time Frame

During operation

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annelies Moerman, MD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Website of the University Hospital Ghent

Learn more about this trial

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

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