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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: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Congenital Heart Surgery
Cardiopulmonary Bypass
Intervention: Drug: Phenoxybenzamine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Dates of Recruitment: June 2006 to September 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Phenoxybenzamine Treatment Treatment Group- patients treated with phenoxybenzamine

Participant Flow:   Overall Study
    Phenoxybenzamine Treatment
STARTED   87 [1] 
COMPLETED   87 
NOT COMPLETED   0 
[1] Total number in the study



  Baseline Characteristics

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.
Patients undergoing open heart surgery and who are less than 18 years of age.

Reporting Groups
  Description
Phenoxybenzamine

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

Baseline Measures
   Phenoxybenzamine 
Overall Participants Analyzed 
[Units: Participants]
 		 87 
Age 
[Units: Participants]
Count of Participants 		 
Participants Analyzed 
[Units: Participants]
 		 87 
<=18 years      87 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Participants Analyzed 
[Units: Participants]
 		 87 
Female      42  48.3% 
Male      45  51.7% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants 		  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
Count of Participants 		 
United States   
Participants Analyzed 
[Units: Participants]
 		 87 
United States   87 


  Outcome Measures

1.  Primary:   Number of Participants Achieving 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 ]
  Show Outcome Measure 1

2.  Secondary:   Mortality   [ Time Frame: 30 days ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events


  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
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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Muhammad A. Mumtaz, MD
Organization: Cleveland Clinic
phone: 216 444 9125
e-mail: mumtazm@ccf.org



Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00620945     History of Changes
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