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

Tracking Information

First Received Date ^ICMJE

September 25, 2007

Last Updated Date

April 9, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cerebral saturation [ Time Frame: During operation ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Cerebral saturation [ Time Frame: During operation ]

Change History

Complete list of historical versions of study NCT00535808 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Cerebral Oxygenation

Intervention ^ICMJE

Drug: nitroprusside
Drug: nitroglycerine
Drug: sevoflurane

Study Arms / Comparison Groups

Experimental: Administration of nitroprusside
Experimental: Administration of nitroglycerine
Experimental: Administration of sevoflurane

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Annelies Moerman, MD

0032/(0)9/240.46.62

annelies.moerman@ugent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT ID ^ICMJE

NCT00535808

Responsible Party

Annelies Moerman, University Hospital Ghent

Study ID Numbers ^ICMJE

2007/270

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Annelies Moerman, MD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP