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

NCT00620945 | Terminated Results DMC

• 1 other identifier: CCF IRB # 06-494
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

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

Conditions

Congenital Heart Surgery; Cardiopulmonary Bypass

Keywords

Congenital heart surgery; Cardiopulmonary bypass; Phenoxybenzamine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving High Flow Low Pressure on Cardiopulmonary Bypass

  Percentage of patients who achieved high flow, low pressure on cardiopulmonary bypass

  From time of cardiopulmonary bypass initiation until the time that high flow, low pressure on cardiopulmonary bypass was achieved, assessed up to 1 hour

Secondary Outcomes (1)

• Mortality

  30 days

Study Arms (1)

1

EXPERIMENTAL

Treatment Group

Drug: Phenoxybenzamine

Interventions

Phenoxybenzamine DRUG

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

Also known as: Dibenzyline

1

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

MeSH Terms

Interventions

Phenoxybenzamine

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals

Limitations and Caveats

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.

Results Point of Contact

• Title: Muhammad A. Mumtaz, MD
• Organization: Cleveland Clinic

mumtazm@ccf.org

216 444 9125

Study Officials

• Muhammad A Mumtaz, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 22, 2008
• Study Start: June 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 19, 2017
• Results First Posted: November 20, 2017

Record last verified: 2017-11