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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Alcohol Withdrawal Delirium, Alcohol Withdrawal Associated Autonomic Hyperactivity, Alcohol Withdrawal Hallucinosis, Alcohol Withdrawal-Induced Delirium Tremens

In brief

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.

Key facts

Study ID

NCT01362205

Run by

Denver Health and Hospital Authority

People needed

49

Starts

2012-03-01

Expected to finish

2016-09-01

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• autonomic hyperactivity (e.g., sweating or pulse rate greater than 100)
• increased hand tremor
• insomnia
• nausea or vomiting
• transient visual, tactile, or auditory hallucinations or illusions
• psychomotor agitation
• anxiety
• 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

You may not qualify if…

• 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.

Where it is running

• Memorial Hospital Central — Colorado Springs, Colorado, United States
• Memorial Hospital North — Colorado Springs, Colorado, United States
• Denver Health Medical Center, Medical ICU — Denver, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• St. Anthony Hospital — Lakewood, Colorado, United States
• Louisiana State University — New Orleans, Louisiana, United States
• Ben Taub Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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