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NCT07810946
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Conditions: Alcohol Withdrawal, Alcohol Abstinence, Alcohol Use Disorder
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 75
Sponsor: University of Colorado, Denver
Location: University of Colorado, Anshcutz Medical Campus Aurora Colorado
Summary
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.
Eligibility Criteria
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 (\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
Source: ClinicalTrials.gov (NCT07810946). StuddyBuddy aggregates publicly available trial information.