Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

University of Arkansas

Status and phase: Completed; Phase 2

Conditions: Open-heart Surgery; Cardiopulmonary Bypass

Treatments: Drug: Phenoxybenzamine

Study type: Interventional

Funder types: Other

Identifiers

NCT00569855

06611

Details and patient eligibility

About

Cardiopulmonary bypass is done with a machine that does the work of the heart and lungs during open-heart surgery. This study is to determine if intravenous (i.v.) phenoxybenzamine is safe. This drug lowers the blood pressure, making it easier for the cardiopulmonary bypass machine to deliver blood and oxygen to all of the organs and tissues.

Enrollment: 785 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 0-18 years of age
• weight of less than or equal to 20 kilograms

Exclusion criteria

• Parental refusal to give informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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785 participants in 1 patient group

1

Experimental group

Description:

Receive phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery

Treatment:

Drug: Phenoxybenzamine