At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 785 enrolled
Drug / intervention
Phenoxybenzaminedrug
Likely dose
Phenoxybenzamine 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery
In Brief
A Phase 2 clinical trial evaluating Phenoxybenzamine for Open-heart Surgery and Cardiopulmonary Bypass. Completed, enrolled 785 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpen-heart Surgery, Cardiopulmonary Bypass
CountriesUnited States
CollaboratorsArkansas Children's Hospital Research Institute
Timeline
Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2001
First PostedDec 2007
Primary CompletionAug 2010
TodayJul 2026
First PostedDec 10, 2007
Enrollment StartFeb 1, 2001
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 18.6 years ago
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