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

This study has been terminated.
(DSMB recommendation for slow enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01362205
First Posted: May 30, 2011
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ivor Douglas, Denver Health and Hospital Authority
Results First Submitted: May 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Alcohol Withdrawal Delirium
Alcohol Withdrawal Associated Autonomic Hyperactivity
Alcohol Withdrawal Hallucinosis
Alcohol Withdrawal-Induced Delirium Tremens
Interventions: Drug: Dexmedetomidine
Drug: Placebos

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dexmedetomidine

Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.

Dexmedetomidine: See arm details

Placebo

Blinded placebo study drug administration in equal volume per hour as active study medication arm.

Placebo: Sterile, clear saline 0.9%


Participant Flow:   Overall Study
    Dexmedetomidine   Placebo
STARTED   22   27 
COMPLETED   22   27 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dexmedetomidine

Dexmedetomidine titrated to achieve predefined goals on selected components of the MINDS score using the minimum amount of medication possible. Blinded study medication will be started at a rate determined by the MINDS score. The maximum infusion rate is 1.4 μg/kg per hour. Uncontrolled SAWS/D symptoms, will be treated with open label lorazepam according to the MINDS score algorithm. Persistent SAWS/D symptoms despite maximum infusion rate of study medication treatment limiting symptoms while receiving higher infusion rates of study medication, ancillary therapies will be administered according to the MINDS score algorithm, at the discretion of the treating physician.

Dexmedetomidine: See arm details

Placebo

Blinded placebo study drug administration in equal volume per hour as active study medication arm.

Placebo: Sterile, clear saline 0.9%

Total Total of all reporting groups

Baseline Measures
   Dexmedetomidine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   27   49 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.5  (11.54)   48.2  (11.82)   47.4  (11.61) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  27.3%      3  11.1%      9  18.4% 
Male      16  72.7%      24  88.9%      40  81.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2   9.1%      8  29.6%      10  20.4% 
Not Hispanic or Latino      20  90.9%      19  70.4%      39  79.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      1   3.7%      1   2.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  13.6%      2   7.4%      5  10.2% 
White      19  86.4%      24  88.9%      43  87.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   22   27   49 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Length of ICU Stay Defined as the Time Between Randomization and ICU Transfer Orders.   [ Time Frame: up to 28 days in hours ]

2.  Secondary:   Average MINDS Score   [ Time Frame: up to 28 days ]

3.  Secondary:   The Number of CAM-ICU Negative Days After Randomization.   [ Time Frame: up to 28 days ]

4.  Secondary:   Number of Ventilator Free Days After Randomization.   [ Time Frame: up to 28 days ]

5.  Secondary:   The Length in Days of the Hospital Stay   [ Time Frame: up to 28 days ]

6.  Secondary:   Scores at Hospital Discharge on the Mini Mental Exam.   [ Time Frame: up to 28 days ]

7.  Secondary:   Scores at Hospital Discharge on the Beck Depression Inventory.   [ Time Frame: Up to 28 days. ]

8.  Secondary:   Scores at Hospital Discharge on the Beck Anxiety Inventory   [ Time Frame: Up to 28 days. ]

9.  Secondary:   Scores at Hospital Discharge on the PTSD Civilian Checklist   [ Time Frame: Up to 28 days ]

10.  Secondary:   Resource Utilization Costs Associated With This Hospitalization Billed by Physicians.   [ Time Frame: up to 28 Days ]

11.  Secondary:   Resource Utilization Costs Associated With This Hospitalization Billed by Facility.   [ Time Frame: Up to 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to slow enrollment leading to small numbers of subjects analyzed


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Katie Overdier RN
Organization: Denver Health Medical Center
phone: 303 602 1479
e-mail: Katie.Overdier@dhha.org


Publications:

Responsible Party: Ivor Douglas, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01362205     History of Changes
Other Study ID Numbers: COMIRB 09-0822
First Submitted: May 24, 2010
First Posted: May 30, 2011
Results First Submitted: May 16, 2017
Results First Posted: July 17, 2017
Last Update Posted: November 6, 2017