Phenobarbital vs Ativan for Alcohol Withdrawal in the Intensive Care Unit (PARTI)

October 6, 2020 updated by: Bhagat Aulakh, OSF Healthcare System

Phenobarbital Versus Ativan for Refractory Alcohol Withdrawal Treatment in the Intensive Care Unit

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • This study is a prospective, open-label, randomized, controlled trial.
  • The electronic medical record will be used to identify patients who have a diagnosis of alcohol withdrawal or are receiving alcohol withdrawal. Subjects who are anticipated to meet inclusion criteria will be pre-consented for the study using an informed consent process. see informed consent form.
  • Subjects will not be enrolled and randomized until they have met inclusion criteria.
  • If a patient meets criteria, but is deemed non-decisional or unable to give consent, the patient's medical decision maker will undergo the informed consent process.
  • After enrollment, participants will be randomized to either the control group (lorazepam-based therapy) or the study group (phenobarbital-based therapy)
  • Personnel unassociated with patient screening, enrollment, or follow up will create the allocation sequence and will use a random, computerized number generator. The allocation sequence will then be transferred to sequentially numbered, opaque envelopes for purposes of allocation concealment. These sequentially numbered envelopes, which are blinded to clinical trial coordinators/physicians, will be handed out in order as patients are enrolled. Clinical trial coordinators/physicians will verify treatment eligibility and informed consent before opening the envelope to obtain the treatment assignment.
  • The study group will be placed on the phenobarbital-based protocol as described below in procedures. The control group will be placed on the lorazepam-based protocol, also listed below in procedures.
  • All medications in the study are FDA approved. No investigational medicines will be used.
  • Data will be collected on each participant as noted below in measurements.
  • The data will be analyzed and published as noted above in the statistical analysis plan and data use and management section.

Study Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Phenobarbital
Phenobarbital loading dose followed by a taper will be given to control acute alcohol withdrawal syndrome
Other Names:
  • solfoton
  • luminal
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.
Drug: Lorazepam
Ativan will be given according to our institutional alcohol withdrawal protocol to control acute alcohol withdrawal syndrome
Other Names:
  • ativan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: study completion, up to 18 months
number of days in the intensive care unit
study completion, up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: Study completion, up to 18 months
number of days in the hospital
Study completion, up to 18 months
30-day readmission
Time Frame: study complettion, up to 18 months
rate of readmission of patients within 30 days for any cause
study complettion, up to 18 months
mortality
Time Frame: Study completion, up to 18 months
number of deaths
Study completion, up to 18 months
Intubation
Time Frame: study completion, up to 18 months
rate of endotracheal intubation
study completion, up to 18 months
Hospitalization cost
Time Frame: Study completion, up to 18 months
Cost of index hospital stay
Study completion, up to 18 months
Lorazepam use
Time Frame: Study completion, up to 18 months
total lorazepam use in mg during the entire hospital stay
Study completion, up to 18 months
dexmedetomidine use
Time Frame: Study completion, up to 18 months
total dexmedetomidine used in mcg during the entire hospital stay
Study completion, up to 18 months
propofol use
Time Frame: Study completion, up to 18 months
total propofol used in mg during the entire hospital stay
Study completion, up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OSF Healthcare System

Investigators

  • Principal Investigator: Bhagat Aulakh, MD, OSF HealthCare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1499413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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