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
Results First Received: January 12, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Open-heart Surgery
Cardiopulmonary Bypass
Intervention: Drug: Phenoxybenzamine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The patient population eligible for enrollment included those pediatric patients 20 kilograms or less in weight undergoing open-heart surgery requiring extracorporeal circulation (cardiopulmonary bypass) at Arkansas Children’s Hospital, regardless of their gender or ethnic background

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
n/a

Reporting Groups
  Description
Subjects Who Received Study Drug Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg

Participant Flow:   Overall Study
    Subjects Who Received Study Drug  
STARTED     785 [1]
COMPLETED     785 [2]
NOT COMPLETED     0  
[1] 832 subjects enrolled; however, study records only available for analysis from 2004 =446 subjects
[2] 785 subjects treated with study drug



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Subjects Who Received Study Drug Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg

Baseline Measures
    Subjects Who Received Study Drug  
Number of Participants  
[units: participants]
  785  
Age  
[units: participants]
 
<=18 years     785  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     390  
Male     395  
Region of Enrollment  
[units: participants]
 
United States     785  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Research Program Manager, Cardiovascular Surgery, Dept. of Pediatrics
Organization: University of Arkansas, Arkansas Children's Hospital, Dept. of Pediatrics
phone: 501-364-1100 ext 5859
e-mail: althagekarena@uams.edu


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