CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 128 enrolled
Drug / intervention
Clonidine (without protocolized initiation) +1 moredrug
Likely dose
Clonidine (protocolized initiation) 1 mcg/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/NCT05575219
NCT05575219Phase 4Completed

Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal: A Prospective Cohort Study

The University of Texas Health Science Center, Houston·interventional·Posted Oct 12, 2022·Updated Jan 28, 2025

In Brief

A Phase 4 clinical trial evaluating Clonidine (without protocolized initiation) and Clonidine (protocolized initiation) for Withdrawal; Therapeutic Substance. Completed, enrolled 128 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if the protocolized use of clonidine will reduce dexmedetomidine withdrawal symptoms, reduce PICU length of stay, and reduce costs related to sedation during hospital admission.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedOct 12, 2022
Enrollment StartOct 8, 2022
Primary CompletionFeb 15, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 3.7 years ago

Interventions

Clonidine (without protocolized initiation)drug

Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.

Clonidine (protocolized initiation)drug

* Observe participants without initiating clonidine with dexmedetomidine infusion time of 72-119 hours. To wean off dexmedetomidine, decrease the infusion by 25% of the starting dose every 6 hours. * Begin clonidine at 1 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of 120-144 hours. * Begin clonidine at 1.5 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion times of 145-167 hours. * Begin clonidine at 2 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of \>/= 168 hours or with infusion time of 120-167 hours at doses \>/= 1.1 mcg/kg/min. * If clonidine is started decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours).