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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Dexmedetomidine (Precedex®), With Lorazepam Rescue, for the Management of Severe Alcohol Withdrawal Syndrome (AWS) and Alco

Brief 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.


Detailed Summary:

Severe alcohol withdrawal syndrome (AWS) and alcohol withdrawal delirium (AWD) are frequent principal indication/s for admission to intensive care units. Additionally, unanticipated alcohol withdrawal complicates other critical illnesses and peri-operative states. Alcohol intoxication and withdrawal syndrome are characterized by classic symptoms of adrenergic activation, psychiatric agitation including seizures, as well as metabolic and respiratory dysfunction. The majority of patients with severe AWS are effectively managed with combinations of benzodiazepine (BZD) sedatives (e.g. lorazepam) and butyrophenone antipsychotics (e.g. haloperidol) and require intensive care admission for 2-3 days. However, almost 25% of patients with SAWS have a prolonged critical care course, often complicated by respiratory failure and associated with excessive sedation and risk for complications such as ventilator-associated pneumonia (VAP). AWS is frequently difficult to manage with usual care including benzodiazepines. Additionally, while intermittent bolus dose sedation is recommended for AWS, high dose BZD alone is associated with excessive respiratory suppression and metabolic acidosis. Such therapy increases the likelihood of respiratory failure with its attendant complications of hospital acquired pneumonia and sepsis. Further, patients with underlying chronic liver disease are at greater risk for prolonged sedative effects of BZD and progression of hepatic encephalopathy. The requirement for mechanical ventilation additionally prolongs the course of treatment for AWD because of the need for prolonged sedation. Strategies to control AWS/AWD that control symptoms but avoid adverse effects of excessive respiratory suppression are anticipated to improve the short and medium-term outcomes of AWS.

BZD infusions have also been shown by several investigators to result in excessive and prol
Sponsor: Denver Health and Hospital Authority

Current Primary Outcome: The length of ICU stay defined as the time between randomization and ICU transfer orders. [ Time Frame: up to 28 days in hours ]

Original Primary Outcome: The time to achieve resolution of AWS/AWD as defined by a score of < 2 on the Minnesota Detoxification Scale (MINDS) [ Time Frame: up to 28 days in hours ]

Current Secondary Outcome:

  • The number of delirium-free and ventilator-free days during the first 28 days of hospitalization [ Time Frame: up to 28 days ]
  • The length in days of the hospital stay [ Time Frame: up to 28 days ]
  • Scores at hospital discharge on the Mini Mental Exam, Beck Depression Inventory, Beck Anxiety Inventory and PTSD checklist. [ Time Frame: up to 28 days ]
  • Resource utilization costs associated with this hospitalization. [ Time Frame: up to 28 Days ]
  • Predefined adverse events [ Time Frame: up to 28 days ]
  • average MINDS score [ Time Frame: up to 28 days ]


Original Secondary Outcome:

  • The number of delirium-free and ventilator-free days during the first 28 days of hospitalization [ Time Frame: up to 28 days ]
  • The length of ICU and hospital stays [ Time Frame: up to 28 days ]
  • Mini Mental scores on hospital discharge [ Time Frame: up to 28 days ]
  • Psychometric battery: Wechsler Adult Intelligence Test, Revised Wechsler Memory Scale, Revised Verbal Fluency Test, Beck Depression Inventory, Beck Anxiety Inventory, and SF36 instrument for assessment of Quality of Life, at hospital discharge [ Time Frame: up to 28 days ]
  • Resource utilization costs associated with this hospitalization. [ Time Frame: up to 28 Days ]
  • Blood pressure meeting the definition of an adverse event [ Time Frame: Hours ]
  • Heart rate meeting the definition of an adverse event. [ Time Frame: Hours ]


Information By: Denver Health and Hospital Authority

Dates:
Date Received: May 24, 2010
Date Started: March 2012
Date Completion: September 2017
Last Updated: April 14, 2017
Last Verified: April 2017