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

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: September 25, 2007
Last updated: July 12, 2012
Last verified: July 2012
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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

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

Enrollment: 30
Study Start Date: October 2007
Study Completion Date: March 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


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00535808

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

Additional Information:
Responsible Party: University Hospital, Ghent Identifier: NCT00535808     History of Changes
Other Study ID Numbers: 2007/270
Study First Received: September 25, 2007
Last Updated: July 12, 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 processed this record on September 21, 2017