UnknownPhase 4

Phenobarbital vs Ativan for Alcohol Withdrawal in the Intensive Care Unit

United States142 participantsStarted 2020-07-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ICU length of stay

Timeframe: study completion, up to 18 months

Trial details

NCT IDNCT04156464

SponsorOSF Healthcare System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-01

Contact for this trial

Rachael M Davis, MD

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

View on ClinicalTrials.gov More Alcohol Withdrawal trials