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Sponsors and Collaborators: |
University of Arkansas Arkansas Children's Hospital Research Institute |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00569855 |
Cardiopulmonary bypass is done with a machine that does the work of the heart and lungs during open-heart surgery. This study is to determine if intravenous (i.v.) phenoxybenzamine is safe. This drug lowers the blood pressure, making it easier for the cardiopulmonary bypass machine to deliver blood and oxygen to all of the organs and tissues.
Condition | Intervention | Phase |
---|---|---|
Open-Heart Surgery Cardiopulmonary Bypass |
Drug: Phenoxybenzamine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery |
Estimated Enrollment: | 5000 |
Study Start Date: | February 2001 |
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
Receive phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery
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Drug: Phenoxybenzamine
0.125 to 1 mg/kg given i.v. over 15 to 45 minutes in preparation for cardiopulmonary bypass; may be continued at 0.125 mg/kg/day in ICU
|
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: William Fiser, MD | 501-364-5858 | FiserWilliamP@uams.edu |
United States, Arkansas | |
Arkansas Children's Hospital | Recruiting |
Little Rock, Arkansas, United States, 72207 | |
Principal Investigator: Michiaki Imamura, MD |
Principal Investigator: | Michiaki Imamura, MD | Arkansas Childrens Hospital |
Responsible Party: | University of Arkansas for Medical Sciences ( Carole Hamon ) |
Study ID Numbers: | 06611 |
Study First Received: | December 6, 2007 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00569855 |
Health Authority: | United States: Food and Drug Administration |
Phenoxybenzamine |
Neurotransmitter Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Therapeutic Uses Physiological Effects of Drugs |
Adrenergic Antagonists Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |