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

December 6, 2007
February 3, 2011
February 2001
August 2010   (final data collection date for primary outcome measure)
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
Incidence of Significant Hypotension [ Time Frame: proactive ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00569855 on ClinicalTrials.gov Archive Site
Not Provided
Contributing Factors (congestive heart failure, hypovolemia) [ Time Frame: proactive ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery
Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Open-heart Surgery
  • Cardiopulmonary Bypass
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
Experimental: 1
Receive phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery
Intervention: Drug: Phenoxybenzamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
785
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Parental refusal to give informed consent
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00569855
06611
No
Carole Hamon, University of Arkansas for Medical Sciences
University of Arkansas
Arkansas Children's Hospital Research Institute
Principal Investigator: Michiaki Imamura, MD Arkansas Childrens Hospital
University of Arkansas
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP