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

NCT01362205 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2017-11-06

Study results available
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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.

Conditions

  • Alcohol Withdrawal Delirium
  • Alcohol Withdrawal Associated Autonomic Hyperactivity
  • Alcohol Withdrawal Hallucinosis
  • Alcohol Withdrawal-Induced Delirium Tremens

Interventions

DRUG

Dexmedetomidine

DRUG

Placebos

Inactive placebo (normal saline)

Sponsors & Collaborators

  • Denver Health and Hospital Authority

    lead OTHER

Principal Investigators

  • Ivor S Douglas, MD, FRCP · Denver Health Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-12-31
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01362205 on ClinicalTrials.gov