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

Sponsor:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00535808

Purpose

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.

Condition	Intervention	Phase
Cerebral Oxygenation	Drug: nitroprusside Drug: nitroglycerine Drug: sevoflurane	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: a Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy

Drug Information available for: Nitroglycerin Sodium nitroprusside Nitroprusside Sevoflurane

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	October 2007
Estimated Study Completion Date:	June 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Administration of nitroprusside	Drug: nitroprusside Administration of nitroprusside
Experimental: 2 Administration of nitroglycerine	Drug: nitroglycerine Administration of nitroglycerine
Experimental: 3 Administration of sevoflurane	Drug: sevoflurane Administration of Sevoflurane

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535808

Locations

Belgium
University Hospital Ghent
Ghent, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Annelies Moerman, MD

University Hospital, Ghent

More Information

Additional Information:

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Annelies Moerman, University Hospital Ghent
ClinicalTrials.gov Identifier:	NCT00535808 History of Changes
Other Study ID Numbers:	2007/270
Study First Received:	September 25, 2007
Last Updated:	May 30, 2011
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:

Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Nitroglycerin
Nitroprusside
Sevoflurane
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 13, 2012