University of Colorado, Denver
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.
Alcohol withdrawal syndrome manifests in up to 30% of hospitalized patients with severe alcohol use disorders (AUD), and is a potentially life-threatening, highly morbid condition. Standard medications to treat alcohol withdrawal (e.g. benzodiazepines) can induce respiratory depression and prolong hospitalization, while medications used as adjuncts (e.g. dexmedetomidine) are also sedating and necessitate intensive monitoring. Therefore, alternative treatments targeting novel pathways in alcohol withdrawal are needed to address this treatment gap and improve patient care. Although alcohol withd…
Inclusion Criteria: * Active treatment for alcohol withdrawal (e.g. use of protocolized order set in an inpatient setting) * Inpatient admission ordered * Adult \> 21 years old Exclusion Criteria: * End-stage renal disease or likely need for renal replacement therapy in the next 12 hours * Heart failure with reduced ejection fraction (\<30%) * Receipt of \>2L crystalloids prior to randomization * Advanced liver disease (Child's C or D) * Uncontrolled mental health condition * \>24 hours since ED arrival * Pregnant or incarcerated * Unable to consent and/or no proxy
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.
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