Dexmedetomidine (Precedex®) for Severe Alcohol Withdrawal Syndrome (AWS) and Alcohol Withdrawal Delirium (AWD)

• Status: Terminated
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, double-blind, placebo-controlled, parallel-group study of dexmedetomidine versus placebo, with lorazepam rescue, for the management of severe alcohol withdrawal syndrome (AWS) and alcohol withdrawal delirium (AWD) in critically ill adults.

The investigators hypothesize that the integration of dexmedetomidine (Precedex®) with usual therapy for the management of severe alcohol withdrawal syndrome (AWS) and alcohol withdrawal delirium/delirium tremens (AWD) in critically ill adult patients will reduce the time to resolution of AWS/AWD, increase the number of delirium-free and ventilator-free days in the first 28 days of hospitalization, reduce the length of ICU and hospital stays, and improve neurocognitive and quality of life scores on hospital discharge.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denver Health and Hospital Authority
• Treatments: Dexmedetomidine; Ethanol; Lorazepam

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.