Status:
COMPLETED
Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Hospira, now a wholly owned subsidiary of Pfizer
Conditions:
Acute Alcohol Withdrawal
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol withdrawal of medical ICU patients. Specifically, this study will assess whether adjunctive dexmedetomidine r...
Detailed Description
The objectives of this randomized, double-blind, placebo controlled, dose escalation study are a) to determine if adding dexmedetomidine to symptom-triggered, standard therapy of severe alcohol withdr...
Eligibility Criteria
Inclusion
- Severe alcohol withdrawal defined by a CIWA score ≥ 15 and the need for at least 16 mg of lorazepam over a four-hour period. All lorazepam doses, whether oral or intravenous, will contribute to the cumulative amount.
- Patients receiving standard therapy for severe alcohol withdrawal according to a symptom-triggered alcohol withdrawal protocol. Lorazepam is the preferred benzodiazepine agent for patients requiring ICU admission due to alcohol withdrawal.
- Informed consent within 36 hours of qualifying for the study.
Exclusion
- Patients \< 18 years of age or \> 85 years of age.
- Patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation).
- Patients with alcohol withdrawal not requiring ICU admission.
- Patients receiving epidural administration of medication(s).
- Comatose patients by metabolic or neurologic affectation.
- Patients with active myocardial ischemia or second- or third-degree heart block.
- Moribund state with planned withdrawal of life support.
- Patients with known or suspected severe adverse reactions to dexmedetomidine (or clonidine).
- Pregnant females or females suspected of being pregnant
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00936377
Start Date
September 1 2009
End Date
October 1 2012
Last Update
May 12 2016
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045