Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

Cardiopulmonary Bypass Clinical Trial

Official title:

Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569855
• Other study ID #: 06611
• Status: Completed
• Phase: Phase 2
• First received: December 6, 2007
• Last updated: February 3, 2011
• Start date: February 2001
• Est. completion date: August 2010

Study information

• Verified date: February 2011
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 785
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 0-18 years of age

• weight of less than or equal to 20 kilograms

Exclusion Criteria:

• Parental refusal to give informed consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Open-heart Surgery

Intervention

Drug:
• Phenoxybenzamine
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

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	72 hours postoperatively	Yes