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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2008 by The Cleveland Clinic
Information provided by:
The Cleveland Clinic Identifier:
First received: February 11, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted

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 Intervention
Congenital Heart Surgery
Cardiopulmonary Bypass
Drug: Phenoxybenzamine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • High flow low pressure perfusion [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: June 2006
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:


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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00620945

Contact: Muhammad A Mumtaz, MD 2164449125
Contact: Brian W Duncan, MD 2164449365

United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Muhammad A Mumtaz, MD    216-444-9125   
Principal Investigator: Muhammad A Mumtaz, MD         
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Muhammad A Mumtaz, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Muhammad A. Mumtaz, MD, Cleveland Clinic Foundation Identifier: NCT00620945     History of Changes
Other Study ID Numbers: CCF IRB # 06-494
Study First Received: February 11, 2008
Last Updated: February 11, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents processed this record on October 08, 2015