At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 56 enrolled

Drug / intervention

Dexmedetomidinedrug

Likely dose

Dexmedetomidine 0.35mcg/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.

Search/NCT00573066

NCT00573066Phase 1Completed

Compare CT.gov

The Pharmacokinetics, Pharmacogenetics, and Pharmacodynamics of Dexmedetomidine In Infants Post-Operative From Cardiac Surgery

Athena Zuppa·interventional·Posted Dec 13, 2007·Updated Apr 9, 2013

In Brief

A Phase 1 clinical trial evaluating Dexmedetomidine for Hypoplastic Left Heart and 2 related conditions. Completed, enrolled 56 participants.

Detailed Summary

This study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication. This medication, for the purpose of this trial, is used as a short-term sedative for infants who are immediately post-operative from cardiac surgery and have a breathing tube and are breathing with the assistance of a mechanical ventilator or breathing machine.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHypoplastic Left Heart, Tetralogy of Fallot, Tricuspid Atresia

Countries--

Collaborators--

Timeline

Phase 1CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2004

Primary CompletionOct 2006

First PostedDec 2007

TodayJul 2026

First PostedDec 13, 2007

Enrollment StartMay 1, 2004

Primary CompletionOct 1, 2006

TodayJul 2, 2026

Enrollment to primary: 2.4 yearsPosted 18.6 years ago

Interventions

Dexmedetomidinedrug

Dosage levels: Dose Level 1: Loading dose 0.35mcg/kg and CIVI 0.25mcg/kg/hr Dose Level 2: Loading Dose of 0.7mcg/kg and CIVI 0.5mcg/kg/hr and Dose Level 3: Loading Dose 1 mcg/kg and CIVI 0.75 mcg/kg/hr.