NCT02404077

Brief Summary

The investigators' clinical practice makes use of oral clonidine as a means of transitioning from intravenous dexmedetomidine following prolonged infusions (more than 3-5 days). Although this is common clinical practice, there is limited clinical data to demonstrate the efficacy of this technique and to provide clonidine dosing guidelines. The purpose of this study is to retrospectively review the investigators' experience with the use of oral clonidine to prevent withdrawal following the prolonged administration of dexmedetomidine.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
712

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

March 24, 2015

Last Update Submit

April 19, 2017

Conditions

Sedation

Keywords

PatientsundergoingICU

Outcome Measures

Primary Outcomes (1)

  • Evidence of withdrawal

    Withdrawal is assessed using the Withdrawal Assessment Tool-1 (WAT-1). The 19-item assessment consists of (1) a review of the patient's record for the past 12 hours, (2) direct observation of the patient for 2 minutes, (3) patient assessment during a progressive stimulated exam routinely performed to assess level of consciousness at the beginning of each 12-hour shift, and finally (4) assessment of post-stimulus recovery.

    Twice a day from the first day of taper of dexmedetomidine until 72 hrs. after the last dose

Study Arms (1)

Clonidine

Patients who received clonidine following prolonged dexmedetomidine infusions

Drug: Clonidine

Interventions

ClonidineDRUG
Clonidine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients who have been on prolonged dexmedetomidine infusions.

You may qualify if:

  • Patients who received clonidine during the transition from dexmedetomidine.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Joseph D Tobias, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

March 24, 2015

First Posted

March 31, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 20, 2017

Record last verified: 2017-04