Intravenous Acetate for Alcohol Withdrawal Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
Alcohol withdrawal syndrome is a highly morbid condition affecting a substantial percentage of patients hospitalized who have alcohol use disorders, estimated at 5-6% of all hospitalized patients. Standard treatment paradigms for alcohol withdrawal syndrome have common and serious side effects, and do not fully address this condition's underlying pathophysiology.
This study will examine the feasibility and safety of administering intravenous acetate, an alcohol metabolite and alternative brain fuel, as an adjunctive treatment for alcohol withdrawal in hospitalized patients that will to set the stage for future investigations of its efficacy as an adjunctive treatment in the hospital setting.
Who Is on the Research Team?
Ellen Burnham, MD
Principal Investigator
University of Colorado, Department of Pulmonary, Allergy and Critical Care Medicine
Are You a Good Fit for This Trial?
This trial is for hospitalized adults experiencing alcohol withdrawal. Participants must have a history of problem drinking or alcoholism and be currently going through withdrawal symptoms. People with certain medical conditions or who are unable to safely receive IV treatments may not be eligible.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Sodium Acetate
Trial Overview
The study tests if giving intravenous sodium acetate, alongside usual care, is safe and practical for treating alcohol withdrawal in the hospital. Some patients will get sodium acetate while others get a placebo (inactive treatment), assigned randomly.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Sodium acetate (82mg/mEq) will be mixed in solution with sterile water to create a 150 mEq/L (same as 150 mM) isotonic solution. Patients randomized to active drug will initially receive 300 mM (mEq) acetate in 2L fluid over a two-hour period. The study drug will be administered as an initial 6 mg/kg/min bolus (\~250mL volume) over 10 min, followed by a 3 mg/kg/min infusion (1750ml volume) over 110 min to complete 2L total. After the two hours are completed, patients will continue to receive the acetate solution infusion at a reduced rate of 50 mL/hour (or 615 mg acetate/ hour) until alcohol withdrawal orders are discontinued, or up to 72 hours, whichever comes first.
The placebo solution will be 0.9% saline, administered as a bolus/infusion in a manner identical to what would be administered for acetate.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
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