Trial Outcomes & Findings for Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal (NCT NCT00936377)
NCT ID: NCT00936377
Last Updated: 2016-05-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Seven days
Results posted on
2016-05-12
Participant Flow
Participant milestones
| Measure |
Dexmedetomidine, Low Dose
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Dexmedetomidine, High Dose
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Placebo
Normal saline
Placebo: Normal saline for five days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal
Baseline characteristics by cohort
| Measure |
Dexmedetomidine, Low Dose
n=8 Participants
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Dexmedetomidine, High Dose
n=8 Participants
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Placebo
n=8 Participants
Normal saline
Placebo: Normal saline for five days.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47 years
n=5 Participants
|
50 years
n=7 Participants
|
51 years
n=5 Participants
|
49.3 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Weight
|
87.1 kg
n=5 Participants
|
84.5 kg
n=7 Participants
|
81.5 kg
n=5 Participants
|
84.4 kg
n=4 Participants
|
|
Acute Physiologic And Chronic Health Evaluation (APACHE) III
|
69.5 units on a scale
n=5 Participants
|
56.5 units on a scale
n=7 Participants
|
49.5 units on a scale
n=5 Participants
|
58.5 units on a scale
n=4 Participants
|
|
Endotracheal Intubation at Study Entry
Intubated
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Endotracheal Intubation at Study Entry
Not intubated
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Child-Pugh Score
|
7 units on a scale
n=5 Participants
|
6 units on a scale
n=7 Participants
|
6 units on a scale
n=5 Participants
|
6.3 units on a scale
n=4 Participants
|
|
Lorazepam requirement 24 Hour Prior to Study Entry
|
94 mg
n=5 Participants
|
75 mg
n=7 Participants
|
39 mg
n=5 Participants
|
69.3 mg
n=4 Participants
|
|
Time from Study Qualification to Study Drug Start
|
17.1 hours
n=5 Participants
|
13.5 hours
n=7 Participants
|
10.4 hours
n=5 Participants
|
14 hours
n=4 Participants
|
PRIMARY outcome
Timeframe: Seven daysOutcome measures
| Measure |
Dexmedetomidine, Low Dose
n=8 Participants
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Dexmedetomidine, High Dose
n=8 Participants
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Placebo
n=8 Participants
Normal saline
Placebo: Normal saline for five days.
|
|---|---|---|---|
|
Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal
|
180.5 mg
Interval 79.3 to 223.4
|
112.5 mg
Interval 48.8 to 746.8
|
109.1 mg
Interval 40.9 to 227.4
|
PRIMARY outcome
Timeframe: 12 hours before treatment, 12 hours after treatment on first day of starting study drugOutcome measures
| Measure |
Dexmedetomidine, Low Dose
n=8 Participants
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Dexmedetomidine, High Dose
n=8 Participants
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Placebo
n=8 Participants
Normal saline
Placebo: Normal saline for five days.
|
|---|---|---|---|
|
Change in 12-Hour Lorazepam Requirement Pre- and Post-Treatment
|
-42.5 mg
Interval -52.7 to -1.6
|
-34.3 mg
Interval -61.9 to -14.5
|
-17.5 mg
Interval -24.3 to 36.7
|
PRIMARY outcome
Timeframe: 24 hours before treatment, 24 hours after treatment on first day of starting study drugOutcome measures
| Measure |
Dexmedetomidine, Low Dose
n=8 Participants
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Dexmedetomidine, High Dose
n=8 Participants
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Placebo
n=8 Participants
Normal saline
Placebo: Normal saline for five days.
|
|---|---|---|---|
|
Change in 24-Hour Lorazepam Requirement Pre- and Post-Treatment
|
-62.1 mg
Interval -118.0 to -8.8
|
-45 mg
Interval -68.9 to -16.8
|
-8 mg
Interval -31.3 to 76.2
|
SECONDARY outcome
Timeframe: Every 2-4 hours for 24 hours after starting study drugProportion of clinical institute withdrawal assessment (CIWA) Scores listed as severe or moderate 24 Hours after Starting Study Drug. All subjects had at least four CIWA assessments.The CIWA is a ten item scale with each item on the scale scored independently on a 0-7 or 0-4 scale, and the summation of the scores yielding an aggregate value that correlates to the severity of alcohol withdrawal. Ranges of scores are from 0 to 67. Mild alcohol withdrawal is defined with a score less than or equal to 15, moderate with scores of 16 to 20, and severe with any score greater than 20. The ten items evaluated include nausea and vomiting, tremor, sweats, anxiety, agitation, tactile disturbances, auditory disturbances, visual disturbances, headache, and orientation.
Outcome measures
| Measure |
Dexmedetomidine, Low Dose
n=8 Participants
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Dexmedetomidine, High Dose
n=8 Participants
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Placebo
n=8 Participants
Normal saline
Placebo: Normal saline for five days.
|
|---|---|---|---|
|
The Degree of Alcohol Withdrawal Assessed by Clinical Institute Withdrawal Assessment (CIWA) Scores
severe
|
11 percentage of ciwa assessment
|
15 percentage of ciwa assessment
|
25 percentage of ciwa assessment
|
|
The Degree of Alcohol Withdrawal Assessed by Clinical Institute Withdrawal Assessment (CIWA) Scores
moderate
|
31 percentage of ciwa assessment
|
24 percentage of ciwa assessment
|
22 percentage of ciwa assessment
|
SECONDARY outcome
Timeframe: Seven daysOccurrence of hypotension or bradycardia while on study drug
Outcome measures
| Measure |
Dexmedetomidine, Low Dose
n=8 Participants
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Dexmedetomidine, High Dose
n=8 Participants
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Placebo
n=8 Participants
Normal saline
Placebo: Normal saline for five days.
|
|---|---|---|---|
|
The Occurrence of Adverse Events.
Hypotension
|
1 participants
|
2 participants
|
0 participants
|
|
The Occurrence of Adverse Events.
Bradycardia
|
1 participants
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Four days with samples measured prior to study drug and 48 and 96 hours after starting study drugPlasma epinephrine concentrations
Outcome measures
| Measure |
Dexmedetomidine, Low Dose
n=8 Participants
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Dexmedetomidine, High Dose
n=8 Participants
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Placebo
n=8 Participants
Normal saline
Placebo: Normal saline for five days.
|
|---|---|---|---|
|
Plasma Epinephrine Concentrations Across Groups Over Time
Baseline
|
0.27 ng/mL
Standard Deviation 0.17
|
0.29 ng/mL
Standard Deviation 0.1
|
0.31 ng/mL
Standard Deviation 0.25
|
|
Plasma Epinephrine Concentrations Across Groups Over Time
Time 48 hours
|
0.27 ng/mL
Standard Deviation 0.47
|
0.21 ng/mL
Standard Deviation 0.09
|
0.27 ng/mL
Standard Deviation 0.17
|
|
Plasma Epinephrine Concentrations Across Groups Over Time
Time 96 hours
|
0.26 ng/mL
Standard Deviation 0.33
|
0.27 ng/mL
Standard Deviation 0.17
|
0.3 ng/mL
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: The duration of study drug in hours as measured when the subject was discharged from the ICU, for up to 24 weeksOutcome measures
| Measure |
Dexmedetomidine, Low Dose
n=8 Participants
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Dexmedetomidine, High Dose
n=8 Participants
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Placebo
n=8 Participants
Normal saline
Placebo: Normal saline for five days.
|
|---|---|---|---|
|
Duration of Study Drug Administration
|
53.1 hours
Interval 39.4 to 89.5
|
78 hours
Interval 22.1 to 112.5
|
70.3 hours
Interval 25.0 to 120.0
|
SECONDARY outcome
Timeframe: The duration of ICU stay in days as measured at time of hospital discharge, for up to 24 weeksOutcome measures
| Measure |
Dexmedetomidine, Low Dose
n=8 Participants
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Dexmedetomidine, High Dose
n=8 Participants
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Placebo
n=8 Participants
Normal saline
Placebo: Normal saline for five days.
|
|---|---|---|---|
|
ICU Length of Stay
|
5.5 days
Interval 2.5 to 9.9
|
3.8 days
Interval 2.4 to 10.0
|
4 days
Interval 1.9 to 7.1
|
Adverse Events
Dexmedetomidine, Low Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dexmedetomidine, High Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexmedetomidine, Low Dose
n=8 participants at risk
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Dexmedetomidine, High Dose
n=8 participants at risk
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
|
Placebo
n=8 participants at risk
Normal saline
Placebo: Normal saline for five days.
|
|---|---|---|---|
|
Cardiac disorders
Hypotension
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
|
Cardiac disorders
Bradycardia
|
12.5%
1/8 • Number of events 1
|
37.5%
3/8 • Number of events 3
|
0.00%
0/8
|
|
Cardiac disorders
Hypertension
|
37.5%
3/8 • Number of events 3
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place