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Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569855
First Posted: December 10, 2007
Last Update Posted: March 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Arkansas Children's Hospital Research Institute
Information provided by:
University of Arkansas
December 6, 2007
December 10, 2007
January 12, 2011
March 1, 2011
March 1, 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 ]
Number of subjects who required Norepinephrine >0.1mcq/kg/min
Incidence of Significant Hypotension [ Time Frame: proactive ]
Complete list of historical versions of study NCT00569855 on ClinicalTrials.gov Archive Site
Not Provided
Contributing Factors (congestive heart failure, hypovolemia) [ Time Frame: proactive ]
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: None (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
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00569855
06611
No
Not Provided
Not Provided
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