Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

University of Arkansas785 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

785

Conditions

Open-heart Surgery Cardiopulmonary Bypass

Interventions

PhenoxybenzamineDRUG

0.125 to 1 mg/kg given i.v. over 15 to 45 minutes in preparation for cardiopulmonary bypass; may be continued at 0.125 mg/kg/day in ICU

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 0-18 years of age * weight of less than or equal to 20 kilograms Exclusion Criteria: * Parental refusal to give informed consent

Locations (1)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively

Number of subjects who required Norepinephrine \>0.1mcq/kg/min

Time frame: 72 hours postoperatively

Data from ClinicalTrials.gov

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