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Use of Phenoxybenzamine [PBZ] IV to Assist High Flow Low Pressure Perfusion [HFLPP] on Cardio-pulmonary Bypass

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ClinicalTrials.gov Identifier: NCT00620945
Recruitment Status : Terminated (New protocol now being used for cardiopulmonary bypass)
First Posted : February 22, 2008
Results First Posted : November 20, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Congenital Heart Surgery
Cardiopulmonary Bypass
Intervention Drug: Phenoxybenzamine
Enrollment 87
Recruitment Details Dates of Recruitment: June 2006 to September 2008
Pre-assignment Details  
Arm/Group Title Phenoxybenzamine Treatment
Hide Arm/Group Description Treatment Group- patients treated with phenoxybenzamine
Period Title: Overall Study
Started 87 [1]
Completed 87
Not Completed 0
[1]
Total number in the study
Arm/Group Title Phenoxybenzamine
Hide Arm/Group Description

Treatment Group

Phenoxybenzamine: Use of Phenoxybenzamine:

Loading dose given at the time of going on CPB:

  • For patients with obstructing lesions on systemic side:

    • 0.25 mg/kg dose in the bypass circuit
    • None intravenous
  • For patients without obstructing left sided lesions:

    • 0.5 mg/kg in the bypass circuit
    • 0.5 mg/kg I.V. at cannulation

Maintenance dose given in the post-operative period:

  • 0.3 mg/kg I.V. every 8 hours till oral intake is started or for first 48 hours
  • 0.3 mg/kg P.O. every 8 hours for next 24 hours
  • 0.15 mg/kg P.O. every 8 hours for next 24 hours and then stop
  • Hold PBZ if the patient is on norepinephrine infusion or the mean arterial pressure is lower than that allowed for the age group
Overall Number of Baseline Participants 87
Hide Baseline Analysis Population Description
Patients undergoing open heart surgery and who are less than 18 years of age.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants
<=18 years
87
 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 87 participants
Female
42
  48.3%
Male
45
  51.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 87 participants
87
 100.0%
1.Primary Outcome
Title Number of Participants Achieving High Flow Low Pressure on Cardiopulmonary Bypass
Hide Description Percentage of patients who achieved high flow, low pressure on cardiopulmonary bypass
Time Frame From time of cardiopulmonary bypass initiation until the time that high flow, low pressure on cardiopulmonary bypass was achieved, assessed up to 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenoxybenzamine Treatment
Hide Arm/Group Description:
Treatment Group- patients treated with phenoxybenzamine
Overall Number of Participants Analyzed 87
Measure Type: Count of Participants
Unit of Measure: Participants
87
 100.0%
2.Secondary Outcome
Title Mortality
Hide Description Percentage of patients who died within 30 days of the procedure
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenoxybenzamine Treatment
Hide Arm/Group Description:
Treatment Group- patients treated with phenoxybenzamine
Overall Number of Participants Analyzed 87
Measure Type: Count of Participants
Unit of Measure: Participants
5
   5.7%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phenoxybenzamine
Hide Arm/Group Description

Treatment Group

Phenoxybenzamine: Use of Phenoxybenzamine:

Loading dose given at the time of going on CPB:

  • For patients with obstructing lesions on systemic side:

    • 0.25 mg/kg dose in the bypass circuit
    • None intravenous
  • For patients without obstructing left sided lesions:

    • 0.5 mg/kg in the bypass circuit
    • 0.5 mg/kg I.V. at cannulation

Maintenance dose given in the post-operative period:

  • 0.3 mg/kg I.V. every 8 hours till oral intake is started or for first 48 hours
  • 0.3 mg/kg P.O. every 8 hours for next 24 hours
  • 0.15 mg/kg P.O. every 8 hours for next 24 hours and then stop
  • Hold PBZ if the patient is on norepinephrine infusion or the mean arterial pressure is lower than that allowed for the age group
All-Cause Mortality
Phenoxybenzamine
Affected / at Risk (%)
Total   5/87 (5.75%)    
Hide Serious Adverse Events
Phenoxybenzamine
Affected / at Risk (%) # Events
Total   5/87 (5.75%)    
Cardiac disorders   
Myocardial dysfunction * [1]  3/87 (3.45%)  3
Vascular disorders   
Pulmonary hypertension *  2/87 (2.30%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Cause of death was myocardial dysfunction, pulmonary hypertension, or myocardial infarction
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phenoxybenzamine
Affected / at Risk (%) # Events
Total   0/87 (0.00%)    
Due to a change in leadership the protocol of cardiopulmonary bypass was changed on 9/22/2008. The high flow low pressure perfusion is no longer used. As a result phenoxybenzamine was no longer able to be studied and the study was closed early.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Muhammad A. Mumtaz, MD
Organization: Cleveland Clinic
Phone: 216 444 9125
EMail: mumtazm@ccf.org
Layout table for additonal information
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00620945    
Other Study ID Numbers: CCF IRB # 06-494
First Submitted: February 11, 2008
First Posted: February 22, 2008
Results First Submitted: October 20, 2017
Results First Posted: November 20, 2017
Last Update Posted: December 19, 2017