Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

Phase 2

Completed

• Conditions: Open-heart Surgery; Cardiopulmonary Bypass
• Interventions: Drug: Phenoxybenzamine

• Registration Number: NCT00569855
• Lead Sponsor: University of Arkansas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2007-12-06
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-10
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2011-01-12
• Status Verified: 2011-02
• Results First Submitted QC: 2011-02-03
• Last Update Submitted: 2011-02-03
• Results First Posted: 2011-03-01
• Last Update Posted: 2011-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 785

Inclusion Criteria

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

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Exclusion Criteria

• Parental refusal to give informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Phenoxybenzamine	Receive phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery

Primary Outcome Measures

Name	Time	Method
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	72 hours postoperatively	Number of subjects who required Norepinephrine \>0.1mcq/kg/min

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States