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| Sponsored by: |
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: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: a Randomized Study |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Administration of nitroprusside
|
Drug: nitroprusside
Administration of nitroprusside
|
|
2: Experimental
Administration of nitroglycerine
|
Drug: nitroglycerine
Administration of nitroglycerine
|
|
3: Experimental
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Annelies Moerman, MD | 0032/(0)9/240.46.62 | annelies.moerman@ugent.be |
| Belgium | |
| University Hospital Ghent | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Annelies Moerman, MD 0032/(0)9/240.46.62 annelies.moerman@ugent.be | |
| Principal Investigator: Annelies Moerman, MD | |
| Principal Investigator: | Annelies Moerman, MD | University Hospital, Ghent |
More Information
| Responsible Party: | University Hospital Ghent ( Annelies Moerman ) |
| Study ID Numbers: | 2007/270 |
| Study First Received: | September 25, 2007 |
| Last Updated: | April 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00535808 History of Changes |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
|
Vasodilator Agents Heart Diseases Cardiovascular Abnormalities Central Nervous System Depressants Anesthetics Cardiovascular Agents Antihypertensive Agents Aortic Coarctation Sevoflurane |
Nitric Oxide Donors Nitroglycerin Nitric Oxide Anesthetics, Inhalation Anesthetics, General Nitroprusside Platelet Aggregation Inhibitors Congenital Abnormalities Heart Defects, Congenital |
|
Vasodilator Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Cardiovascular Abnormalities Physiological Effects of Drugs Hematologic Agents Central Nervous System Depressants Anesthetics Cardiovascular Agents Antihypertensive Agents Aortic Coarctation Pharmacologic Actions |
Nitric Oxide Donors Sevoflurane Nitroglycerin Anesthetics, Inhalation Anesthetics, General Therapeutic Uses Nitroprusside Platelet Aggregation Inhibitors Cardiovascular Diseases Congenital Abnormalities Central Nervous System Agents Heart Defects, Congenital |
