CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
Dexmedetomidinedrug
Likely dose
Dexmedetomidine 1 microgramfrom 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.

Search/NCT00480740
NCT00480740Phase 3Completed
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The Pharmacology of Dexmedetomidine in Children With Congenital Heart Disease

Children's National Research Institute·interventional·Posted May 31, 2007·Updated Jun 26, 2015

In Brief

A Phase 3 clinical trial evaluating Dexmedetomidine for Cardiac Transplant and 3 related conditions. Completed, enrolled 41 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Transplant, Patent Ductus Arterious, Atrial Septal Defect, Bidirectional Cavopulmonary Anastomosis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 31, 2007
Enrollment StartDec 1, 2006
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 19.1 years ago

Interventions

Dexmedetomidinedrug

Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization