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NCT05575219 · ClinicalTrials.gov registry record · Phase 4

Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal

A Phase 4 study of Withdrawal; Therapeutic Substance, sponsored by The University of Texas Health Science Center, Houston.

Completed
Registry status
Phase 4
Development phase
128
Enrollment target
1
Study location

NCT05575219: Completed Phase 4 study of Withdrawal; Therapeutic Substance, sponsored by The University of Texas Health Science Center, Houston.

NCT05575219 is a Phase 4 study of Withdrawal; Therapeutic Substance that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 128 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05575219, a Phase 4 study of Withdrawal; Therapeutic Substance, has completed, sponsored by The University of Texas Health Science Center, Houston.

COMPLETED
Registry status
Phase 4
Development phase
128 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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 dexmedetomid

Interventions

  • DRUG Clonidine (without protocolized initiation)
  • DRUG Clonidine (protocolized initiation)

Study Locations (1)

Texas

  • Children's Memorial Hermann Hospital - Houston

Trial Details

FieldValue
Enrollment Target 128 participants
Start Date 2022-10-08
Est. Completion 2024-02-15
Phase Phase 4

What the finished NCT05575219 record still lists

NCT05575219 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).

The record links to 1 condition, with Withdrawal; Therapeutic Substance appearing as the primary indexed condition, and to 2 interventions - of which Clonidine (without protocolized initiation) is the first listed.

NCT05575219 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT05575219 about?

NCT05575219 is a clinical study titled "Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal". 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.

What is the current status of trial NCT05575219?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 128 participants. The study started on 2022-10-08. Estimated completion is 2024-02-15.

What conditions does trial NCT05575219 study?

This clinical trial studies the following conditions: Withdrawal; Therapeutic Substance.

What interventions are being tested in trial NCT05575219?

The interventions under investigation include: Clonidine (without protocolized initiation) (DRUG), Clonidine (protocolized initiation) (DRUG).

Who is sponsoring clinical trial NCT05575219?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05575219 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT05575219's enrollment target sits among peer trials

128 634th of 2000 higher than 1,362 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05575219, the US trial registry maintained by the National Library of Medicine. NCT05575219 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.