Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal

January 2, 2025 updated by: Andrea Leigh Heifner, The University of Texas Health Science Center, Houston

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Children's Memorial Hermann Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Dexmedetomidine infusion for greater than or equal to 72 hours

Exclusion Criteria:

  • Admission for head trauma
  • Psychiatric history
  • Use of alpha-2 agonist medications at home
  • Death while on dexmedetomidine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care (without protocolized clonidine initiation)
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Drug: Clonidine (without protocolized initiation)
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Other Names:
  • Clondine
Experimental: Intervention (protocolized clonidine initiation)
A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.
Drug: Clonidine (protocolized initiation)
  • 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).
Other Names:
  • Clondine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Withdrawal
Time Frame: from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days)

The number of participants with withdrawal is reported. Withdrawal is defined as: (increase in heart rate, systolic blood pressure, and/or diastolic blood pressure by at least 10% from the 24 hours prior to dexmedetomidine weaning to the 24 hours after dexmedetomidine is discontinued) AND (two documented WAT (Withdrawal assessment tool)-1 scores of ≥ 3 and/or two study questionnaire scores of ≥ 3). WAT and questionnaire scores will be collected every 12 hours starting with the first dexmedetomidine wean until 72 hours after dexmedetomidine is discontinued.

WAT-1 is a scoring tool used to evaluate symptoms of withdrawal with a total score that ranges from 0 to 12. The higher the score the more severe the withdrawal.

The study questionnaire is used to evaluate degree of agitation and/or insomnia with a total score that ranges from 0 to 7, a higher score indicates higher degrees of agitation and/or insomnia.
from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hours on Dexmedetomidine
Time Frame: During time in Pediatric Intensive Care Unit (about 260 Hours)
number of total hours on dexmedetomidine
During time in Pediatric Intensive Care Unit (about 260 Hours)
Pediatric Intensive Care Unit (PICU) Length of Stay
Time Frame: During time in Pediatric Intensive Care Unit (about 10 to 30 days)
number of days in the PICU
During time in Pediatric Intensive Care Unit (about 10 to 30 days)
Dexmedetomidine Cost Per Kilogram During Hospitalization
Time Frame: During time in Pediatric Intensive Care Unit (about 24 days)
During time in Pediatric Intensive Care Unit (about 24 days)
Clonidine Cost Per Kilogram During Hospitalization
Time Frame: During time in Pediatric Intensive Care Unit (about 24 days)
During time in Pediatric Intensive Care Unit (about 24 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Andrea Heifner, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2022

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 7, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-22-0410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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