Alcohol Withdrawal Clinical Trial
Official title:
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.
- 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.
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