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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Open-heart Surgery
Cardiopulmonary Bypass
Intervention Drug: Phenoxybenzamine
Enrollment 785
Recruitment Details 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  
Arm/Group Title Subjects Who Received Study Drug
Hide Arm/Group Description 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
Period Title: Overall Study
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
Arm/Group Title Subjects Who Received Study Drug
Hide Arm/Group Description 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
Overall Number of Baseline Participants 785
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 785 participants
<=18 years
785
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 785 participants
Female
390
  49.7%
Male
395
  50.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 785 participants
785
1.Primary Outcome
Title 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
Hide Description Number of subjects who required Norepinephrine >0.1mcq/kg/min
Time Frame 72 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
No. of subjects consented = 832; 785 subjects received study drug
Arm/Group Title Subjects Who Received Study Drug
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 785
Measure Type: Number
Unit of Measure: participants
25
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subjects Who Received Study Drug
Hide Arm/Group Description 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
All-Cause Mortality
Subjects Who Received Study Drug
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Subjects Who Received Study Drug
Affected / at Risk (%) # Events
Total   2    
Surgical and medical procedures   
Early Death- defined as death within 72 hours of treatment with study drug 1 [1]  2/785 (0.25%)  2
1
Term from vocabulary, death
[1]
AE=early death as defined as death within 72 hours of treatment; cause of death was not analyzed.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subjects Who Received Study Drug
Affected / at Risk (%) # Events
Total   0/785 (0.00%)    
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.
Results Point of Contact
Layout table for Results Point of Contact information
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
EMail: althagekarena@uams.edu
Layout table for additonal information
Responsible Party: Carole Hamon, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00569855    
Other Study ID Numbers: 06611
First Submitted: December 6, 2007
First Posted: December 10, 2007
Results First Submitted: January 12, 2011
Results First Posted: March 1, 2011
Last Update Posted: March 1, 2011