Trial Outcomes & Findings for Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (NCT NCT02856594)
NCT ID: NCT02856594
Last Updated: 2023-03-20
Results Overview
Confusion Assessment Method
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
469 participants
Primary outcome timeframe
Post operative day 1 (24 hours)
Results posted on
2023-03-20
Participant Flow
There were no significant events in the study following enrollment but prior to assignment of participants to an arm or group. All enrolled subjects were assigned to either of the two study groups.
Participant milestones
| Measure |
Dexmedetomidine-induced Sleep
Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.
Dexmedetomidine: Dexmedetomidine
|
Placebo
Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
234
|
235
|
|
Overall Study
Analysis Population
|
188
|
206
|
|
Overall Study
COMPLETED
|
188
|
206
|
|
Overall Study
NOT COMPLETED
|
46
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep
Baseline characteristics by cohort
| Measure |
Dexmedetomidine-induced Sleep
n=188 Participants
Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=206 Participants
Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.
Placebo: Placebo
|
Total
n=394 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
129 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
286 Participants
n=5 Participants
|
|
Age, Continuous
|
67.5 years
n=5 Participants
|
70.0 years
n=7 Participants
|
69.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
179 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
373 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
182 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
384 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Delirium Incidence at Baseline
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Preoperative Cognitive Status
|
19.0 score on a scale
n=5 Participants
|
19.0 score on a scale
n=7 Participants
|
19.0 score on a scale
n=5 Participants
|
|
Preoperative Health Related Quality of Life
Global Health - Physical
|
50.8 Values are reported using a T-Score.
n=5 Participants
|
50.8 Values are reported using a T-Score.
n=7 Participants
|
50.8 Values are reported using a T-Score.
n=5 Participants
|
|
Preoperative Health Related Quality of Life
Global Health - Mental
|
56.0 Values are reported using a T-Score.
n=5 Participants
|
56.0 Values are reported using a T-Score.
n=7 Participants
|
56.0 Values are reported using a T-Score.
n=5 Participants
|
|
Preoperative Health Related Quality of Life
Physical Function
|
44.6 Values are reported using a T-Score.
n=5 Participants
|
46.4 Values are reported using a T-Score.
n=7 Participants
|
45.5 Values are reported using a T-Score.
n=5 Participants
|
|
Preoperative Health Related Quality of Life
Pain Interference
|
40.7 Values are reported using a T-Score.
n=5 Participants
|
40.7 Values are reported using a T-Score.
n=7 Participants
|
40.7 Values are reported using a T-Score.
n=5 Participants
|
|
Preoperative Health Related Quality of Life
Applied Cognition
|
52.4 Values are reported using a T-Score.
n=5 Participants
|
51.2 Values are reported using a T-Score.
n=7 Participants
|
51.7 Values are reported using a T-Score.
n=5 Participants
|
|
Preoperative Health Related Quality of Life
Sleep Disturbance
|
50.5 Values are reported using a T-Score.
n=5 Participants
|
50.5 Values are reported using a T-Score.
n=7 Participants
|
50.5 Values are reported using a T-Score.
n=5 Participants
|
PRIMARY outcome
Timeframe: Post operative day 1 (24 hours)Confusion Assessment Method
Outcome measures
| Measure |
Dexmedetomidine-induced Sleep
n=175 Participants
Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=189 Participants
Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.
Placebo: Placebo
|
|---|---|---|
|
Incidence of Delirium
|
5 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5Confusion Assessment Method
Outcome measures
| Measure |
Dexmedetomidine-induced Sleep
n=160 Participants
Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=177 Participants
Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.
Placebo: Placebo
|
|---|---|---|
|
ICU Delirium/Coma-free Days
0 Days
|
0 Participants
|
2 Participants
|
|
ICU Delirium/Coma-free Days
1 Day
|
6 Participants
|
7 Participants
|
|
ICU Delirium/Coma-free Days
2 Days
|
8 Participants
|
16 Participants
|
|
ICU Delirium/Coma-free Days
3 Days
|
146 Participants
|
152 Participants
|
SECONDARY outcome
Timeframe: Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5Confusion Assessment Method (CAM): Minimum Score=0, Maximum Score=19, Higher Scores: indicate increased severity of delirium
Outcome measures
| Measure |
Dexmedetomidine-induced Sleep
n=160 Participants
Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=177 Participants
Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.
Placebo: Placebo
|
|---|---|---|
|
Severity of Delirium
|
3.0 score on a scale
Interval 2.0 to 4.0
|
3.0 score on a scale
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: Up to postoperative day 180 (6 months)30-day, 90-day, and 180-day mortality
Outcome measures
| Measure |
Dexmedetomidine-induced Sleep
n=188 Participants
Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=206 Participants
Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.
Placebo: Placebo
|
|---|---|---|
|
30-day, 90-day, and 180-day Mortality
In Hospital Mortality
|
3 Participants
|
1 Participants
|
|
30-day, 90-day, and 180-day Mortality
30 Days
|
3 Participants
|
1 Participants
|
|
30-day, 90-day, and 180-day Mortality
90 Days
|
4 Participants
|
1 Participants
|
|
30-day, 90-day, and 180-day Mortality
180 Days
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 days, 90 days, and 180 days postoperativelyTelephone Montreal Cognitive Assessment (tMoCA): Minimum Score=0, Maximum Score=22, Higher Scores: indicate better cognitive function
Outcome measures
| Measure |
Dexmedetomidine-induced Sleep
n=137 Participants
Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=138 Participants
Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.
Placebo: Placebo
|
|---|---|---|
|
Postoperative Cognitive Status
30 Days
|
20.0 score on a scale
Interval 18.0 to 21.0
|
20.0 score on a scale
Interval 19.0 to 21.0
|
|
Postoperative Cognitive Status
90 Days
|
20.0 score on a scale
Interval 19.0 to 21.0
|
20.0 score on a scale
Interval 19.0 to 21.0
|
|
Postoperative Cognitive Status
180 Days
|
20.0 score on a scale
Interval 19.0 to 21.0
|
21.0 score on a scale
Interval 19.0 to 22.0
|
SECONDARY outcome
Timeframe: 30 days, 90 days, and 180 days postoperativelyThis included the PROMIS Global Health SF V.1.1, PROMIS Physical Function SF 8b V.1.2, PROMIS Pain Interference SF 8a V.1.0, PROMIS Applied Cognition Abilities SF 8a V.1.0, and PROMIS Sleep Disturbance SF 4A V.1.0, respectively. Scores from each assessment were converted to a T-score for analysis with a mean of 50 and a standard deviation of 10, with lower scores on the PROMIS Pain Interference SF and PROMIS Sleep Disturbance SF considered better, whereas higher scores on all other assessments were considered better.
Outcome measures
| Measure |
Dexmedetomidine-induced Sleep
n=137 Participants
Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=138 Participants
Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.
Placebo: Placebo
|
|---|---|---|
|
Postoperative Health Related Quality of Life
PROMIS Global Health - Physical (30 Days)
|
50.8 T-Score
Interval 44.9 to 54.1
|
47.7 T-Score
Interval 42.3 to 54.1
|
|
Postoperative Health Related Quality of Life
PROMIS Global Health - Physical (90 Days)
|
54.1 T-Score
Interval 47.7 to 59.8
|
54.1 T-Score
Interval 47.7 to 57.7
|
|
Postoperative Health Related Quality of Life
PROMIS Global Health - Physical (180Days)
|
57.7 T-Score
Interval 50.8 to 61.9
|
54.1 T-Score
Interval 50.8 to 61.9
|
|
Postoperative Health Related Quality of Life
PROMIS Global Health - Mental (30 Days)
|
59.0 T-Score
Interval 50.8 to 67.6
|
56.0 T-Score
Interval 50.8 to 62.5
|
|
Postoperative Health Related Quality of Life
PROMIS Global Health - Mental (90 Days)
|
59.0 T-Score
Interval 53.3 to 67.6
|
62.5 T-Score
Interval 56.0 to 67.6
|
|
Postoperative Health Related Quality of Life
PROMIS Global Health - Mental (180 Days)
|
62.5 T-Score
Interval 53.3 to 67.6
|
62.5 T-Score
Interval 53.3 to 67.6
|
|
Postoperative Health Related Quality of Life
PROMIS Physical Function (30 Days)
|
49.9 T-Score
Interval 40.7 to 55.8
|
52.3 T-Score
Interval 40.7 to 58.1
|
|
Postoperative Health Related Quality of Life
PROMIS Physical Function (90 Days)
|
40.7 T-Score
Interval 40.7 to 51.2
|
40.7 T-Score
Interval 40.7 to 49.9
|
|
Postoperative Health Related Quality of Life
PROMIS Physical Function (180 Days)
|
40.7 T-Score
Interval 40.7 to 47.9
|
40.7 T-Score
Interval 40.7 to 40.7
|
|
Postoperative Health Related Quality of Life
PROMIS Pain Interference (30 Days)
|
49.9 T-Score
Interval 40.7 to 55.8
|
52.3 T-Score
Interval 40.7 to 58.1
|
|
Postoperative Health Related Quality of Life
PROMIS Pain Interference (90 Days)
|
40.7 T-Score
Interval 40.7 to 51.2
|
40.7 T-Score
Interval 40.7 to 49.9
|
|
Postoperative Health Related Quality of Life
PROMIS Pain Interference (180 Days)
|
40.7 T-Score
Interval 40.7 to 47.9
|
40.7 T-Score
Interval 40.7 to 40.7
|
|
Postoperative Health Related Quality of Life
PROMIS Applied Cognition (30 Days)
|
54.6 T-Score
Interval 48.6 to 62.7
|
53.0 T-Score
Interval 47.7 to 62.7
|
|
Postoperative Health Related Quality of Life
PROMIS Applied Cognition (90 Days)
|
53.0 T-Score
Interval 49.5 to 62.7
|
54.6 T-Score
Interval 47.7 to 62.7
|
|
Postoperative Health Related Quality of Life
PROMIS Applied Cognition (180 Days)
|
54.6 T-Score
Interval 47.7 to 62.7
|
54.6 T-Score
Interval 48.6 to 62.7
|
|
Postoperative Health Related Quality of Life
PROMIS Sleep Disturbance (30 Days)
|
50.5 T-Score
Interval 43.8 to 56.1
|
50.5 T-Score
Interval 43.8 to 56.1
|
|
Postoperative Health Related Quality of Life
PROMIS Sleep Disturbance (90 Days)
|
48.4 T-Score
Interval 43.8 to 52.4
|
48.4 T-Score
Interval 41.1 to 52.4
|
|
Postoperative Health Related Quality of Life
PROMIS Sleep Disturbance (180 Days)
|
46.2 T-Score
Interval 41.1 to 51.5
|
46.2 T-Score
Interval 41.1 to 50.5
|
SECONDARY outcome
Timeframe: perioperativeBlood samples will be taken including whole blood, serum, TruCulture, and PAXgene to assess proteins, DNA, and RNA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: intraoperativeEEG burst suppression and alpha power will be analyzed for association with delirium.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: from postoperative day 0 until date of hospital discharge (no prespecified length possible)Medical Record Review
Outcome measures
| Measure |
Dexmedetomidine-induced Sleep
n=188 Participants
Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.
Dexmedetomidine: Dexmedetomidine
|
Placebo
n=206 Participants
Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.
Placebo: Placebo
|
|---|---|---|
|
Length of Hospital Stay
|
6.0 days
Interval 5.0 to 8.0
|
6.0 days
Interval 5.0 to 7.0
|
Adverse Events
Dexmedetomidine-induced Sleep
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr, Oluwaseun Johson-Akeju
Massachusetts General Hospital
Phone: 617-724-7200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place