Trial record 9 of 13 for:
"Aortic coarctation"
Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: A Randomized Study
This study has been completed.
Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00535808
First received: September 25, 2007
Last updated: July 12, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 |
| 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:
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- Cerebral saturation [ Time Frame: During operation ] [ Designated as safety issue: Yes ]
| 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
|
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 More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT00535808 History of Changes |
| Other Study ID Numbers: | 2007/270 |
| Study First Received: | September 25, 2007 |
| Last Updated: | July 12, 2012 |
| 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 June 18, 2013