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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00535808
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : July 13, 2012
Information provided by (Responsible Party):
University Hospital, Ghent

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.

Condition or disease Intervention/treatment Phase
Cerebral Oxygenation Drug: nitroprusside Drug: nitroglycerine Drug: sevoflurane Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Cerebral saturation [ Time Frame: During operation ]

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00535808

University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Principal Investigator: Annelies Moerman, MD University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent Identifier: NCT00535808     History of Changes
Other Study ID Numbers: 2007/270
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Vasodilator Agents
Antihypertensive Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action