We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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):

Study Description
Brief Summary:
Cardiopulmonary bypass [CPB] in small size bodies can result in decreased peripheral perfusion. This results in anaerobic metabolism as evidenced by lactic acidosis. High flow perfusion results in systemic hypertension which is accentuated by moderate hypothermia commonly used during cardiopulmonary bypass. Phenoxybenzamine [PBZ] is an arteriolar vasodilator that acts by irreversibly blocking the alpha adrenergic receptors. It causes vasodilatation allowing high flow, low pressure CPB. It has been used extensively outside US in Canada, Europe and Australia. In the US oral PBZ is FDA approved, whereas intravenous PBZ is only available as an investigational drug

Condition or disease Intervention/treatment
Congenital Heart Surgery Cardiopulmonary Bypass Drug: Phenoxybenzamine

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Phenoxybenzamine [PBZ] IV to Assist High Flow Low Pressure Perfusion [HFLPP] on Cardio-pulmonary Bypass in Infants and Children With Congenital Heart Disease and to Assist Steady State Alfa-blockade in the Intensive Care Phase
Study Start Date : June 2006
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Treatment Group
Drug: 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
Other Name: Dibenzyline


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    Percentage of patients who achieved high flow, low pressure on cardiopulmonary bypass


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    Percentage of patients who died within 30 days of the procedure


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients

The following patients are candidates for receiving PBZ for HFLPP. These include:

  1. All patients under 16 kg.
  2. Those patients between 16-18 kg whose pre bypass hemoglobin is <16 g/dl
  3. All patients are less than 18 years of age

Exclusion Criteria:

  1. Those with bloodless prime in Cardiopulmonary bypass circuit
  2. Age > 18years
  3. Wt. >16 kg
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620945


Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Muhammad A Mumtaz, MD The Cleveland Clinic
More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00620945     History of Changes
Other Study ID Numbers: CCF IRB # 06-494
First Posted: February 22, 2008    Key Record Dates
Results First Posted: November 20, 2017
Last Update Posted: December 19, 2017
Last Verified: November 2017

Keywords provided by The Cleveland Clinic:
Congenital heart surgery
Cardiopulmonary bypass
Phenoxybenzamine

Additional relevant MeSH terms:
Phenoxybenzamine
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents