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NCT01362205 · ClinicalTrials.gov registry record · Phase 4
Dexmedetomidine (Precedex®) for Severe Alcohol Withdrawal Syndrome (AWS) and Alcohol Withdrawal Delirium (AWD)
A Phase 4 study, sponsored by Denver Health and Hospital Authority.
- Terminated
- Registry status
- Phase 4
- Development phase
- 49
- Enrollment target
NCT01362205 is a Phase 4 study that was terminated before completion, run by Denver Health and Hospital Authority. The registered enrollment target is 49 participants.
The verdict
NCT01362205, a Phase 4 study, was terminated before completion, sponsored by Denver Health and Hospital Authority.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 49 participants
- Enrollment target
Study Summary
This is a prospective, randomized, double-blind, placebo-controlled, parallel-group study of dexmedetomidine versus placebo, with lorazepam rescue, for the management of severe alcohol withdrawal syndrome (AWS) and alcohol withdrawal delirium (AWD) in critically ill adults. The investigators hypothesize that the integration of dexmedetomidine (Precedex®) with usual therapy for the management of severe alcohol withdrawal syndrome (AWS) and alcohol withdrawal delirium/delirium tremens (AWD) in critically ill adult patients will reduce the time to resolution of AWS/AWD, increase the number of delirium-free and ventilator-free days in the first 28 days of hospitalization, reduce the length of ICU and hospital stays, and improve neurocognitive and quality of life scores on hospital discharge.
Interventions
- DRUG Placebos
- DRUG Dexmedetomidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01362205
The ClinicalTrials.gov registry entry for NCT01362205 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denver Health and Hospital Authority, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT01362205 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01362205 about?
NCT01362205 is a clinical study titled "Dexmedetomidine (Precedex®) for Severe Alcohol Withdrawal Syndrome (AWS) and Alcohol Withdrawal Delirium (AWD)". This is a prospective, randomized, double-blind, placebo-controlled, parallel-group study of dexmedetomidine versus placebo, with lorazepam rescue, for the management of severe alcohol withdrawal syndrome (AWS) and alcohol withdrawal delirium (AWD) in critically ill adults. The investigators hypoth...
What is the current status of trial NCT01362205?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2012-03. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01362205?
The interventions under investigation include: Placebos (DRUG), Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT01362205?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
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