N/A
N=24
Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal
Acute Alcohol Withdrawal
Bottom Line
View on ClinicalTrials.gov: NCT00936377 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal — 180.5; 112.5; 109.1 mg — p=0.64
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dexmedetomidine (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal |
180.5; 112.5; 109.1 | 0.64 |
| PRIMARY Change in 12-Hour Lorazepam Requirement Pre- and Post-Treatment |
-42.5; -34.3; -17.5 | 0.05 |
| PRIMARY Change in 24-Hour Lorazepam Requirement Pre- and Post-Treatment |
-62.1; -45; -8 | 0.066 |
| SECONDARY The Degree of Alcohol Withdrawal Assessed by Clinical Institute Withdrawal Assessment (CIWA) Scores |
11; 15; 25; 31; 24; 22 | 0.18 |
| SECONDARY The Occurrence of Adverse Events. |
1; 2; 0; 1; 3; 0 | 1 |
| SECONDARY Plasma Epinephrine Concentrations Across Groups Over Time |
0.27; 0.29; 0.31; 0.27; 0.21; 0.27 | <0.05 sig |
| SECONDARY Duration of Study Drug Administration |
53.1; 78; 70.3 | 0.5 |
| SECONDARY ICU Length of Stay |
5.5; 3.8; 4 | 0.43 |
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 reduces the doses of conventional agents used for alcohol withdrawal while maintaining patient comfort and safety and will explore if dexmedetomidine exhibits a dose-dependent profile of action when it is used for this indication. In addition, this study will assess the relationships between alcohol withdrawal, therapy with dexmedetomidine, and potential serum biomarkers of alcohol withdrawal.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Patients 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
Data sourced from ClinicalTrials.gov (NCT00936377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.