Trial | NCT00569855  Report issue

Official Title

Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Study Participants

    785
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 Started
Feb 28
2001
Primary Completion
Aug 31
2010
Study Completion
Aug 31
2010
Results Posted
Mar 01
2011
Estimate
Last Update
Mar 01
2011
Estimate

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

  • Other names: Dibenzyline

1 Experimental

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

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

Parental refusal to give informed consent

Summary

Subjects Who Received Study Drug

All Events

Event Type Organ System Event Term Subjects Who Received Study Drug

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

Subjects Who Received Study Drug

25.0
participants

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Subjects Who Received Study Drug