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Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

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.
 
ClinicalTrials.gov Identifier: NCT00569855
Recruitment Status : Completed
First Posted : December 10, 2007
Results First Posted : March 1, 2011
Last Update Posted : March 1, 2011
Sponsor:
Collaborator:
Arkansas Children's Hospital Research Institute
Information provided by:
University of Arkansas

Tracking Information
First Submitted Date  ICMJE December 6, 2007
First Posted Date  ICMJE December 10, 2007
Results First Submitted Date  ICMJE January 12, 2011
Results First Posted Date  ICMJE March 1, 2011
Last Update Posted Date March 1, 2011
Study Start Date  ICMJE February 2001
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2011)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
Incidence of Significant Hypotension [ Time Frame: proactive ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
Contributing Factors (congestive heart failure, hypovolemia) [ Time Frame: proactive ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery
Official Title  ICMJE Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Open-heart Surgery
  • Cardiopulmonary Bypass
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1
Receive phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery
Intervention: Drug: Phenoxybenzamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2011)
785
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2007)
5000
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Parental refusal to give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00569855
Other Study ID Numbers  ICMJE 06611
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Carole Hamon, University of Arkansas for Medical Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Arkansas
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Arkansas Children's Hospital Research Institute
Investigators  ICMJE
Principal Investigator: Michiaki Imamura, MD Arkansas Childrens Hospital
PRS Account University of Arkansas
Verification Date February 2011

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