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

Sponsored by:	The Cleveland Clinic
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00620945

Purpose

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

MedlinePlus related topics: Heart Surgery

Drug Information available for: Norepinephrine Norepinephrine bitartrate Phenoxybenzamine Phenoxybenzamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment
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

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
1: Experimental 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

Arms

Assigned Interventions

1: Experimental

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

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Patients

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

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

Exclusion Criteria:

Those with bloodless prime in Cardiopulmonary bypass circuit
Age > 18years
Wt. >16 kg

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620945

Contacts

Contact: Muhammad A Mumtaz, MD	2164449125	mumtazm@ccf.org
Contact: Brian W Duncan, MD	2164449365	duncanb@ccf.org

Locations

United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Muhammad A Mumtaz, MD 216-444-9125 mumtazm@ccf.org
Principal Investigator: Muhammad A Mumtaz, MD

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator:

Muhammad A Mumtaz, MD

Cleveland Clinic

More Information

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

Keywords provided by The Cleveland Clinic:

Congenital heart surgery
Cardiopulmonary bypass
Phenoxybenzamine

Study placed in the following topic categories:

Heart Diseases
Norepinephrine
Phenoxybenzamine

Additional relevant MeSH terms:

Neurotransmitter Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs

Adrenergic Antagonists
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009