SedationNCT02404077
Use of Clonidine to Prevent Withdrawal Following Prolonged Dexmedetomidine Infusions
An observational study of Sedation, run by Joseph D. Tobias.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sedation
- What is being tested?
- Clonidine
- Type of treatment
- Injection or infusion
- How many people
- 712 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ICU patients who have been on prolonged dexmedetomidine infusions.
Who may be able to join
- Patients who received clonidine during the transition from dexmedetomidine.
Who cannot join
- None
About this study
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.
- Conditions
- Sedation
- Being tested
- Clonidine
- Keywords
- Patients, undergoing, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Clonidine | Patients who received clonidine following prolonged dexmedetomidine infusions Receives: Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twice a day from the first day of taper of dexmedetomidine until 72 hrs. after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 712 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph D. Tobias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph D Tobias, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404077
- Sponsor's protocol ID
- IRB15-00256
- Status last verified
- Apr 2017
- First submitted
- 24 Mar 2015
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Clonidine to Prevent Withdrawal Following Prolonged Dexmedetomidine Infusions
- ClinicalTrials.gov ID
- NCT02404077
- Acronym / sponsor ID
- IRB15-00256
- Conditions
- Sedation
- Keywords
- Patients, undergoing, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clonidine | – | Drug: ClonidinePatients who received clonidine following prolonged dexmedetomidine infusions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ICU patients who have been on prolonged dexmedetomidine infusions.
Key inclusion criteria (1 listed)
- Patients who received clonidine during the transition from dexmedetomidine.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidine | Drug | Clonidine |
Primary outcome
Evidence of withdrawal
Time frame: Twice a day from the first day of taper of dexmedetomidine until 72 hrs. after the last dose
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph D Tobias, MD principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation, run by Joseph D. Tobias.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of withdrawal (time frame: Twice a day from the first day of taper of dexmedetomidine until 72 hrs. after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.