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Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT05575219
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
12.7
Anticipated Duration (Months)
23.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Clonidine (without protocolized initiation)
  • Drug: Clonidine (protocolized initiation)
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal: A Prospective Cohort Study
Actual Study Start Date :
Oct 8, 2022
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

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 120-167 hours. Decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 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. 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with withdrawal as indicated by score on the Withdrawal Assessment Tool (WAT) [from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-6 days)]

      A WAT score of >/= 3 will indicate withdrawal. Total WAT score range is 0 to 12, and a higher score indicates more significant withdrawal. WAT scores will be collected every 12 hours starting with the first dexmedetomidine wean until 72 hours after dexmedetomidine is discontinued, and any participant with a A WAT score of >/= 3 during this time will be considered to have withdrawal.

    Secondary Outcome Measures

    1. Days on dexmedetomidine [During time in Pediatric Intensive Care Unit (about 5 to 7 days)]

      number of total days of dexmedetomidine

    2. Pediatric Intensive Care Unit (PICU) length of stay [During time in Pediatric Intensive Care Unit (about 5 to 7 days)]

      number of days in the PICU

    3. Sedation costs [During time in Pediatric Intensive Care Unit (about 5 to 7 days)]

      cost during hospitalization for sedation (both enteral and intravenous)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Weeks to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Memorial Hermann Hospital Houston Texas United States 77030

    Sponsors and Collaborators

    • The University of Texas Health Science Center, Houston

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Andrea Leigh Heifner, Clinical Fellow, The University of Texas Health Science Center, Houston
    ClinicalTrials.gov Identifier:
    NCT05575219
    Other Study ID Numbers:
    • HSC-MS-22-0410
    First Posted:
    Oct 12, 2022
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Clonidine

    Study Results

    No Results Posted as of Jan 26, 2023