Recruiting

Phenobarbital vs. Ativan

Sponsor:

OSF Healthcare System

Code:

NCT04156464

Conditions

Alcohol Withdrawal

Alcohol Withdrawal Delirium

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Phenobarbital

Lorazepam

Study Details

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

Study ID

NCT04156464

Start date

Jul 6, 2020

Status verified date

Oct, 2020

Completion date

Mar 1, 2022

Anticipated

Primary completion date

Dec 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients will be eligible for randomization if he/she has met one of the following three conditions:

1. has required more than 10 mg of lorazepam within a one hour time period,
2. has required more than 30 mg of lorazepam within a four hour time period, or
3. requires admission/transfer to the intensive care unit for primarily uncontrolled alcohol withdrawal symptoms

Exclusion Criteria:
  • Patients will be excluded from the study if he/she:

1. has a traumatic brain injury or other neurological condition requiring frequent neurological assessment (stroke, intracranial hemorrhage, active seizures on admission)
2. has severe hypotension requiring vasopressor support
3. is less than 18 years of age
4. is actively pregnant
5. has an allergy to either of the drugs being studied (phenobarbital or lorazepam)
6. is already intubated at the time of randomization

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Phenobarbital based treatment

  • 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.

active comparator: Lorazepam based treatment

  • 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.

Interventions

Phenobarbital

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

Lorazepam

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

Primary outcome measure

  • ICU length of stay [ Time Frame: study completion, up to 18 months ]

Central Contacts and Locations

Central contacts

Rachael M Davis, MD

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

Kimberly L Hartwig, BSN

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

Locations

OSF Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Sara J Riggenbach, BS

309-624-5419sara.j.riggenbach@osfhealthcare.org

Kimberly L Hartwig, BSN

(309) 655-4229kimberly.hartwig@osfhealthcare.org

Principal Investigator:

Bhagat S Aulakh, MD

More Information

Sponsor

OSF Healthcare System

Last update posted

Oct 8, 2020

Last verified

Oct, 2020

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OSF Healthcare System on 2020-10-08.