Phenobarbital vs Ativan for Alcohol Withdrawal in the Intensive Care Unit

NCT04156464 | Unknown Phase 4 FDA Drug

• 1 other identifier: 1499413
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim is to compare outcomes of patients with benzodiazepine-refractory alcohol withdrawal syndrome who are treated with either a phenobarbital-based or a lorazepam based protocol.

Conditions

Alcohol Withdrawal; Alcohol Withdrawal Delirium

Keywords

lorazepam; phenobarbital; ativan; alcohol withdrawal syndrome; alcohol withdrawal; intensive care unit; delirium tremens; refractory alcohol withdrawal; benzodiazepine

Outcome Measures

Primary Outcomes (1)

• ICU length of stay

  number of days in the intensive care unit

  study completion, up to 18 months

Secondary Outcomes (8)

• Hospital length of stay

  Study completion, up to 18 months

• 30-day readmission

  study complettion, up to 18 months

• mortality

  Study completion, up to 18 months

• Intubation

  study completion, up to 18 months

• Hospitalization cost

  Study completion, up to 18 months

Study Arms (2)

Phenobarbital based treatment

ACTIVE COMPARATOR

* The phenobarbital group will undergo management with a phenobarbital based treatment protocol with additional symptom triggered therapies. * On day 1, the phenobarbital group receive a loading dose of phenobarbital intravenous 10mg/kg (actual body weight) with a maximum dose of 1 g/100 mL * On day 2 of study protocol, and no sooner than 12 hours after loading dose, phenobarbital 64.8 mg is administered every 12 hours for two doses. * On day 3 of study protocol, patients will receive phenobarbital 32.4 mg every 12 hours for two doses. * On day 4 of study protocol, patients will receive phenobarbital 32.4 mg once, to be given 24 hours after last scheduled dose. * Throughout the 4 day protocol, the patient will have phenobarbital 65 mg every 6 hours as needed available either IM or IV, starting no sooner than 30 minutes after the loading dose.

Drug: Phenobarbital

Lorazepam based treatment

ACTIVE COMPARATOR

* The lorazepam group will undergo management with a lorazepam based treatment protocol with additional symptom triggered therapies. * On Day 1, the lorazepam group will be started on scheduled lorazepam 4 mg every 6 hours * After day 1, the scheduled lorazepam dose will be modified based on the total lorazepam requirements from the previous day and divided into 4-6 doses. * A lorazepam infusion, at physician discretion, will be available at any point if the dose of scheduled and PRN lorazepam being given is too high or frequent to effectively be administered. * Once symptoms are well controlled on lorazepam based therapy, the total dose given over the past 24 hours will be calculated and weaned by approximately 10-20% per day when clinically appropriate. * Throughout the entire protocol, 2-4 mg lorazepam IV q 30 minutes PRN will be available for a goal CIWA \<6 or RASS -1 to 0.

Drug: Lorazepam

Interventions

Phenobarbital DRUG

Phenobarbital loading dose followed by a taper will be given to control acute alcohol withdrawal syndrome

Also known as: solfoton, luminal

Phenobarbital based treatment

Lorazepam DRUG

Ativan will be given according to our institutional alcohol withdrawal protocol to control acute alcohol withdrawal syndrome

Also known as: ativan

Lorazepam based treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible for randomization if he/she has met one of the following three conditions:
• has required more than 10 mg of lorazepam within a one hour time period,
• has required more than 30 mg of lorazepam within a four hour time period, or
• requires admission/transfer to the intensive care unit for primarily uncontrolled alcohol withdrawal symptoms

You may not qualify if:

• Patients will be excluded from the study if he/she:
• has a traumatic brain injury or other neurological condition requiring frequent neurological assessment (stroke, intracranial hemorrhage, active seizures on admission)
• has severe hypotension requiring vasopressor support
• is less than 18 years of age
• is actively pregnant
• has an allergy to either of the drugs being studied (phenobarbital or lorazepam)
• is already intubated at the time of randomization

Sponsors & Collaborators

• OSF Healthcare System: lead

Study Sites (1)

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Related Publications (28)

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  BACKGROUND

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MeSH Terms

Conditions

Alcohol Withdrawal Delirium

Interventions

Phenobarbital; Lorazepam

Condition Hierarchy (Ancestors)

Alcohol-Induced Disorders, Nervous System; Neurotoxicity Syndromes; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome; Mental Disorders

Intervention Hierarchy (Ancestors)

Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bhagat Aulakh, MD

  OSF Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachael M Davis, MD

CONTACT

309-655-7257; rachael.m.davis@osfhealthcare.org

Kimberly L Hartwig, BSN

CONTACT

309-655-4229; kimberly.hartwig@osfhealthcare.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2 arms

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: November 7, 2019
• Study Start: July 6, 2020
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)