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

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.
 
ClinicalTrials.gov Identifier: NCT01362205
Recruitment Status : Terminated (DSMB recommendation for slow enrollment)
First Posted : May 30, 2011
Results First Posted : July 17, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ivor Douglas, Denver Health and Hospital Authority

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
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description

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

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

Placebo: Sterile, clear saline 0.9%

Period Title: Overall Study
Started 22 27
Completed 22 27
Not Completed 0 0
Arm/Group Title Dexmedetomidine Placebo Total
Hide Arm/Group Description

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

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

Placebo: Sterile, clear saline 0.9%

Total of all reporting groups
Overall Number of Baseline Participants 22 27 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 27 participants 49 participants
46.5  (11.54) 48.2  (11.82) 47.4  (11.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 27 participants 49 participants
Female
6
  27.3%
3
  11.1%
9
  18.4%
Male
16
  72.7%
24
  88.9%
40
  81.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 27 participants 49 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 27 participants 49 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 27 participants 49 participants
22 27 49
1.Primary Outcome
Title The Length of ICU Stay Defined as the Time Between Randomization and ICU Transfer Orders.
Hide Description [Not Specified]
Time Frame up to 28 days in hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

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

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

Placebo: Sterile, clear saline 0.9%

Overall Number of Participants Analyzed 22 27
Median (Inter-Quartile Range)
Unit of Measure: hours
79.2
(43.9 to 134.6)
104.9
(63.7 to 183.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexmedetomidine, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2454
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Average MINDS Score
Hide Description Minnesota Detoxification Scale (MINDS) min score 0, max score 46. The higher the score, the worse the symptoms of AWS/AWD.
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

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

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

Placebo: Sterile, clear saline 0.9%

Overall Number of Participants Analyzed 22 27
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
8.2
(4.6 to 11.0)
9.4
(7.8 to 11.6)
3.Secondary Outcome
Title The Number of CAM-ICU Negative Days After Randomization.
Hide Description The Confusion Assessment Method (CAM)-ICU is a validated instrument used to detect the presence or absence of delirium in the ICU. A delirium free day is counted for any day a patient is negative by the CAM-ICU. The higher the number of CAM-ICU negative days indicates the more days a patient was able to think clearly.
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

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

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

Placebo: Sterile, clear saline 0.9%

Overall Number of Participants Analyzed 22 27
Median (Inter-Quartile Range)
Unit of Measure: days
0.3
(0.0 to 0.5)
0.3
(0.1 to 0.7)
4.Secondary Outcome
Title Number of Ventilator Free Days After Randomization.
Hide Description A ventilator day is counted for any use of invasive mechanical ventilation during a calendar day
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

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

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

Placebo: Sterile, clear saline 0.9%

Overall Number of Participants Analyzed 22 27
Median (Inter-Quartile Range)
Unit of Measure: days
27.5
(25.0 to 28.0)
28.0
(26.0 to 28.0)
5.Secondary Outcome
Title The Length in Days of the Hospital Stay
Hide Description A hospital day is counted for any time on a calendar day the patient is admitted to the hospital. Hospital days are inclusive of ICU days.
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

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

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

Placebo: Sterile, clear saline 0.9%

Overall Number of Participants Analyzed 22 27
Median (Inter-Quartile Range)
Unit of Measure: days
8.0
(5.0 to 13.0)
12.0
(6.0 to 16.0)
6.Secondary Outcome
Title Scores at Hospital Discharge on the Mini Mental Exam.
Hide Description The Mini Mental State Examination or Folstein test is a validated 30-point questionnaire used to measure cognitive impairment (min score 0, max score 30). A score of 24 points (out of a max of 30) indicates normal cognition, less than or equal to 9 points indicates severe impairment, 10-18 indicates moderate impairment and 19-23 mild impairment.
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

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

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

Placebo: Sterile, clear saline 0.9%

Overall Number of Participants Analyzed 22 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
25.8  (2.53) 23.1  (6.09)
7.Secondary Outcome
Title Scores at Hospital Discharge on the Beck Depression Inventory.
Hide Description The Beck Depression Inventory is a validated questionnaire used to measure severity of depression (min score 0, max score 63). The higher the score the greater the severity of depression. A score of 30-63 indicates severe depression, 19-29 moderate depression, 10-18 mild depression and 0-9 minimal depression.
Time Frame Up to 28 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

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

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

Placebo: Sterile, clear saline 0.9%

Overall Number of Participants Analyzed 22 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
26.5  (9.14) 21.4  (10.95)
8.Secondary Outcome
Title Scores at Hospital Discharge on the Beck Anxiety Inventory
Hide Description The Beck Anxiety Inventory is a validated questionnaire used to measure severity of anxiety (min score 0, max score 63). The higher the score the greater the severity of anxiety. A score of 30-63 indicates severe anxiety, 17-29 moderate anxiety, 10-16 mild anxiety and 0-9 minimal anxiety.
Time Frame Up to 28 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

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

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

Placebo: Sterile, clear saline 0.9%

Overall Number of Participants Analyzed 22 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
30.3  (10.83) 21.6  (11.55)
9.Secondary Outcome
Title Scores at Hospital Discharge on the PTSD Civilian Checklist
Hide Description PTSD checklist consists of 17 questions graded on a scale of 1 to 5. The PTSD score is comprised from the sum of the scores 17 questions. The PTSD score has possible values from to 17 to 85 with higher values indicating greater symptom severity.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed was lower than the total included as many patients were discharged quickly upon resolution of altered mental status when a research team member was unavailable to administer the questionnaires.
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

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

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

Placebo: Sterile, clear saline 0.9%

Overall Number of Participants Analyzed 8 12
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
45.5
(39.0 to 59.5)
32.5
(27.5 to 37.0)
10.Secondary Outcome
Title Resource Utilization Costs Associated With This Hospitalization Billed by Physicians.
Hide Description [Not Specified]
Time Frame up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

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

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

Placebo: Sterile, clear saline 0.9%

Overall Number of Participants Analyzed 22 27
Median (Inter-Quartile Range)
Unit of Measure: Dollar (United States)
3482
(2068 to 9326)
4461
(2926 to 8001)
11.Secondary Outcome
Title Resource Utilization Costs Associated With This Hospitalization Billed by Facility.
Hide Description [Not Specified]
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed is less than the number randomized as data was not available for research use at many of the participating institutions.
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

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

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

Placebo: Sterile, clear saline 0.9%

Overall Number of Participants Analyzed 17 23
Median (Inter-Quartile Range)
Unit of Measure: USD
81234
(51437 to 137272)
91651
(67341 to 132458)
Time Frame The first 28 days of hospitalization after randomization.
Adverse Event Reporting Description One subject randomized to the dexmedetomidine group did not receive study drug and so was excluded from the adverse event analysis. The total number of subjects included in the adverse event analysis in the dexmedetomidine decreased from 22 to 21.
 
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description

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

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

Placebo: Sterile, clear saline 0.9%

All-Cause Mortality
Dexmedetomidine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/27 (0.00%) 
Hide Serious Adverse Events
Dexmedetomidine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/21 (23.81%)   3/27 (11.11%) 
Cardiac disorders     
Atrial fibrillation  1  1/21 (4.76%)  0/27 (0.00%) 
Cardiac arrest  1  1/21 (4.76%)  0/27 (0.00%) 
Hepatobiliary disorders     
Hepatitis alcoholic  1  1/21 (4.76%)  0/27 (0.00%) 
Infections and infestations     
Bacteraemia  1  0/21 (0.00%)  1/27 (3.70%) 
Enterococcal infection  1  1/21 (4.76%)  0/27 (0.00%) 
Pneumonia  1  0/21 (0.00%)  1/27 (3.70%) 
Septic shock  1  1/21 (4.76%)  1/27 (3.70%) 
Nervous system disorders     
Haemorrhage intracranial  1  1/21 (4.76%)  0/27 (0.00%) 
Osmotic demyelination syndrome  1  1/21 (4.76%)  0/27 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/21 (4.76%)  0/27 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  0/21 (0.00%)  1/27 (3.70%) 
Respiratory failure  1  2/21 (9.52%)  1/27 (3.70%) 
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dexmedetomidine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   12/21 (57.14%)   17/27 (62.96%) 
Blood and lymphatic system disorders     
Leukocytosis  1  3/21 (14.29%)  1/27 (3.70%) 
Thrombocytosis  1  1/21 (4.76%)  4/27 (14.81%) 
Cardiac disorders     
Bradycardia  1  2/21 (9.52%)  1/27 (3.70%) 
Gastrointestinal disorders     
Diarrhoea  1  3/21 (14.29%)  4/27 (14.81%) 
General disorders     
Oedema peripheral  1  6/21 (28.57%)  11/27 (40.74%) 
Pyrexia  1  4/21 (19.05%)  3/27 (11.11%) 
Infections and infestations     
Urinary tract infection  1  0/21 (0.00%)  2/27 (7.41%) 
Injury, poisoning and procedural complications     
Laceration  1  0/21 (0.00%)  2/27 (7.41%) 
Skin abrasion  1  1/21 (4.76%)  2/27 (7.41%) 
Investigations     
Alanine aminotransferase increased  1  1/21 (4.76%)  3/27 (11.11%) 
Haemoglobin decreased  1  0/21 (0.00%)  3/27 (11.11%) 
Platelet count decreased  1  1/21 (4.76%)  3/27 (11.11%) 
Protein total decreased  1  0/21 (0.00%)  3/27 (11.11%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  0/21 (0.00%)  2/27 (7.41%) 
Hypermagnesaemia  1  2/21 (9.52%)  1/27 (3.70%) 
Hypernatraemia  1  1/21 (4.76%)  4/27 (14.81%) 
Hyperphosphataemia  1  1/21 (4.76%)  3/27 (11.11%) 
Hypoalbuminaemia  1  1/21 (4.76%)  4/27 (14.81%) 
Hypocalcaemia  1  1/21 (4.76%)  2/27 (7.41%) 
Hypokalaemia  1  10/21 (47.62%)  16/27 (59.26%) 
Hypomagnesaemia  1  1/21 (4.76%)  4/27 (14.81%) 
Hyponatraemia  1  2/21 (9.52%)  1/27 (3.70%) 
Hypophosphataemia  1  3/21 (14.29%)  5/27 (18.52%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/21 (9.52%)  0/27 (0.00%) 
Skin and subcutaneous tissue disorders     
Ecchymosis  1  1/21 (4.76%)  3/27 (11.11%) 
Vascular disorders     
Deep vein thrombosis  1  0/21 (0.00%)  2/27 (7.41%) 
Hypertension  1  5/21 (23.81%)  13/27 (48.15%) 
Hypotension  1  6/21 (28.57%)  4/27 (14.81%) 
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Early termination due to slow enrollment leading to small numbers of subjects analyzed
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
Layout table for Results Point of Contact information
Name/Title: Katie Overdier RN
Organization: Denver Health Medical Center
Phone: 303 602 1479
EMail: Katie.Overdier@dhha.org
Layout table for additonal information
Responsible Party: Ivor Douglas, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01362205    
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