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

NCT00620945 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2017-12-19

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Muhammad A Mumtaz, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-02-28
Completion
2009-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00620945 on ClinicalTrials.gov