- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00535808
Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: A Randomized Study
July 12, 2012 updated by: University Hospital, Ghent
Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: a Randomized Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ghent, Belgium, 9000
- University Hospital Ghent
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Administration of nitroprusside
|
Administration of nitroprusside
|
Experimental: 2
Administration of nitroglycerine
|
Administration of nitroglycerine
|
Experimental: 3
Administration of sevoflurane
|
Administration of Sevoflurane
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cerebral saturation
Time Frame: During operation
|
During operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Annelies Moerman, MD, University Hospital, Ghent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
September 25, 2007
First Submitted That Met QC Criteria
September 25, 2007
First Posted (Estimate)
September 26, 2007
Study Record Updates
Last Update Posted (Estimate)
July 13, 2012
Last Update Submitted That Met QC Criteria
July 12, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Congenital Abnormalities
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Aortic Coarctation
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Anesthetics, Inhalation
- Nitric Oxide Donors
- Sevoflurane
- Nitroglycerin
- Nitroprusside
Other Study ID Numbers
- 2007/270
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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