Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

This study is currently recruiting participants.

Verified by University of Arkansas, December 2008

Sponsors and Collaborators:	University of Arkansas Arkansas Children's Hospital Research Institute
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00569855

Purpose

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

MedlinePlus related topics: Heart Surgery

Drug Information available for: Phenoxybenzamine Phenoxybenzamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Incidence of Significant Hypotension [ Time Frame: proactive ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Contributing Factors (congestive heart failure, hypovolemia) [ Time Frame: proactive ] [ Designated as safety issue: No ]

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	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

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

0-18 years of age
weight of less than or equal to 20 kilograms

Exclusion Criteria:

Parental refusal to give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569855

Contacts

Contact: William Fiser, MD

501-364-5858

FiserWilliamP@uams.edu

Locations

United States, Arkansas
Arkansas Children's Hospital	Recruiting
Little Rock, Arkansas, United States, 72207
Principal Investigator: Michiaki Imamura, MD

Sponsors and Collaborators

University of Arkansas

Arkansas Children's Hospital Research Institute

Investigators

Principal Investigator:

Michiaki Imamura, MD

Arkansas Childrens Hospital

More Information

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

Study placed in the following topic categories:

Phenoxybenzamine

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 15, 2009