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

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Phenoxybenzamine

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