Clinical trial NCT04156464: Phenobarbital vs Ativan for Alcohol Withdrawal in the Intensive Care Unit
Official title: Phenobarbital Versus Ativan for Refractory Alcohol Withdrawal Treatment in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alcohol Withdrawal
Alcohol Withdrawal Delirium
Keywords: lorazepam
phenobarbital
ativan
alcohol withdrawal syndrome
alcohol withdrawal
intensive care unit
delirium tremens
refractory alcohol withdrawal
benzodiazepine
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ICU length of stay
timeFrame: study completion, up to 18 months
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Study completion, up to 18 months
measure: 30-day readmission
timeFrame: study complettion, up to 18 months
measure: mortality
timeFrame: Study completion, up to 18 months
measure: Intubation
timeFrame: study completion, up to 18 months
measure: Hospitalization cost
timeFrame: Study completion, up to 18 months
measure: Lorazepam use
timeFrame: Study completion, up to 18 months
measure: dexmedetomidine use
timeFrame: Study completion, up to 18 months
measure: propofol use
timeFrame: Study completion, up to 18 months
Other outcomes:
Locations:
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
Study officials:
affiliation: OSF Healthcare System
name: Bhagat Aulakh, MD
role: PRINCIPAL_INVESTIGATOR
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