Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

This study has been completed.
Sponsor:
Collaborator:
Arkansas Children's Hospital Research Institute
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00569855
First received: December 6, 2007
Last updated: February 3, 2011
Last verified: February 2011
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively [ Time Frame: 72 hours postoperatively ] [ Designated as safety issue: Yes ]
    Number of subjects who required Norepinephrine >0.1mcq/kg/min


Enrollment: 785
Study Start Date: February 2001
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Other Name: Dibenzyline

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72207
Sponsors and Collaborators
University of Arkansas
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Michiaki Imamura, MD Arkansas Childrens Hospital
  More Information

No publications provided

Responsible Party: Carole Hamon, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00569855     History of Changes
Other Study ID Numbers: 06611
Study First Received: December 6, 2007
Results First Received: January 12, 2011
Last Updated: February 3, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Phenoxybenzamine
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on August 28, 2014