TerminatedPhase 4

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

Stopped: DSMB recommendation for slow enrollment

United States49 participantsStarted 2012-03

Plain-language 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.

Who can participate

Age range18 Years – 89 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

The Length of ICU Stay Defined as the Time Between Randomization and ICU Transfer Orders.

Timeframe: up to 28 days in hours

Trial details

NCT IDNCT01362205

SponsorDenver Health and Hospital Authority

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

Results submitted2017-05-16

View on ClinicalTrials.gov More Alcohol Withdrawal Delirium trials