Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT01362205
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients, 18 years or older, with severe AWS or AWD per DSM-IV definitions (below) requiring admission to the ICU for medical management
* Ability to provide informed consent (via a proxy decision maker or patient).
* Within 96 hours of ICU admission.
* Meets DSM-IV diagnostic criteria for 291.8 Alcohol Withdrawal Syndrome:
* Cessation of (or reduction in) alcohol use that has been heavy and prolonged.
* Two (or more) of the following, developing within several hours to a few days after Criterion A:
1. autonomic hyperactivity (e.g., sweating or pulse rate greater than 100)
2. increased hand tremor
3. insomnia
4. nausea or vomiting
5. transient visual, tactile, or auditory hallucinations or illusions
6. psychomotor agitation
7. anxiety
8. grand mal seizures
* The symptoms are not due to a general medical condition and are not better accounted for by another mental disorder.
AND Meets DSM-IV diagnostic criteria for 291.0 Alcohol Intoxication or Withdrawal Delirium
* Disturbance of consciousness
* A change in cognition
* The disturbance develops over a short time and can fluctuate
* Onset is temporal associated with Alcohol Withdrawal Syndrome
Exclusion Criteria:
* Age \< 18 years
* Physician anticipates ICU transfer orders in less than 12 hours from time of consent.
* Recent traumatic brain injury
* Active status epilepticus
* Pregnancy or lactation
* Known allergy or adverse response to any of the study medications
* Requiring glucocorticoid therapy for treatment of acute hepatitis or Stage III (advanced) decompensated liver failure and encephalopathy
* Trauma or burns as admitting diagnoses
* Neuromuscular blockade other than for intubation
* Epidural or spinal analgesia
* General anesthesia 24 hours prior to, or planned after, the start of study drug infusion
* Serious central nervous system pathology (acute stroke, uncontrolled seizures, severe dementia),
* Unstable angina or acute myocardial infarction
* Left ventricular ejection fraction less than 30%
* Heart rate less than 50/min
* Second- or third degree heart block
* Systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion.
* Previous randomization into this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT01362205
Study Brief:
Protocol Section:
NCT01362205