Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Colorado, Denver
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Active treatment for alcohol withdrawal (e.g. use of protocolized order set in an inpatient setting)
Inpatient admission ordered
Adult > 21 years old
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Sodium Acetate
DrugSodium 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.
Placebo
DrugThe placebo solution will be 0.9% saline, administered as a bolus/infusion in a manner identical to what would be administered for acetate.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Intervention (IV acetate)Experimental treatment 1 intervention
Group B: Placebo (normal saline)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Consent Rate for Study Participation per Week
Number and percentage of patients meeting all study eligibility criteria who provide informed consent for study participation among all eligible patients identified during each week of recruitment.
Time frame
Assessed weekly during the study recruitment period, pre-consent2
Proportion of Randomized Participants Receiving Greater Than or Equal to 2 L of Assigned Study Infusion
Number and percentage of randomized participants who receive at least 2 L of their assigned study infusion (study drug or placebo), as a measure of study protocol fidelity.
Time frame
After consent and randomization, immediately before study infusion, through completion or discontinuation of the study infusion, up to 72 hours.3
Proportion of Randomized Participants Withdrawn from Study for Safety Concerns
Number and percentage of randomized participants for whom study participation or study intervention is discontinued because of a safety concern.
Time frame
After consent, immediately before study infusion, through completion, withdraw or discontinuation of the study infusion during the index hospitalization, up to 72 hours.4
Alcohol Withdrawal Medications Administered, per Patient
Alcohol withdrawal medication utilization will be characterized descriptively for each participant by the total dose administered and total number of treatment days. Medications will be summarized by prespecified treatment category: (1) GABAergic medications, including benzodiazepines and phenobarbital, and (2) adjunctive medications, including dexmedetomidine and ketamine. Individual medications and medication classes will be reported separately, as applicable.
Time frame
After consent and randomization, through hospital discharge from the index hospitalization or study completion at 18 months, what occurs first.Secondary outcomes
1
Screening Volume
Number of emergency department patients with an alcohol withdrawal pathway or order set initiated per week. Screening opportunities will also be characterized according to day of the week and time of day when the pathway or order set is initiated.
Time frame
Pre-consent. Assessed weekly during the study recruitment period2
Eligibility Rate
Number and percentage of screened patients meeting all inclusion criteria and no exclusion criteria and therefore eligible to be approached for informed consent.
Time frame
Pre-consent. Assessed weekly during the study recruitment period3
Characteristics of Patients Who Do and Do Not Consent
Characteristics of eligible patients who do and do not consent to study participation will be summarized descriptively, including age, gender, race, ethnicity, English versus Spanish language, comorbid conditions, availability of a proxy, and whether consent was provided by a proxy.
Time frame
Pre-consent through completion of the consent/enrollment attempt during the index hospitalization4
Time to Informed Consent
Time from documented emergency department arrival to documentation of informed consent, determined using electronic medical record date and time stamps.
Time frame
Pre-consent. From emergency department arrival through documentation of informed consentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov
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