NCT04156464

Phenobarbital vs Ativan for Alcohol Withdrawal in the Intensive Care Unit

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: OSF Healthcare System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Alcohol Withdrawal
• Alcohol Withdrawal Delirium

Interventions

Type	Name	Description
DRUG	Phenobarbital	Phenobarbital loading dose followed by a taper will be given to control acute alcohol withdrawal syndrome
DRUG	Lorazepam	Ativan will be given according to our institutional alcohol withdrawal protocol to control acute alcohol withdrawal syndrome

Timeline

• Start date: 2020-07-06
• Primary completion: 2021-12-01
• Completion: 2022-03-01
• First posted: 2019-11-07
• Last updated: 2020-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study