Trial Outcomes & Findings for Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium (NCT NCT00351299)

Results Overview

Resolution of delirium as defined by 2 consecutive negative CAM-ICU assessments. The Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU assesses the four features of delirium: feature 1 is an acute change in mental status or a fluctuating mental status, feature 2 is inattention, feature 3 is altered level of consciousness, and feature 4 is disorganized thinking.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

Up to 7 days

Results posted on

2017-06-09

Participant Flow

Patients admitted to ICU from 2005-2008

Patients enrolled and randomized upon admission to ICU but treated with dexmedetomidine or standard of caremodalities only if they developed delirium.

Participant milestones

Participant milestones
Measure	Infusion of Dexmedetomidine infusion 0.2-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of Care Standard of care per treating physician preference
Overall Study STARTED	25	28
Overall Study COMPLETED	25	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infusion of Dexmedetomidine n=25 Participants infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of Care n=28 Participants Standard of care per treating physician preference	Total n=53 Participants Total of all reporting groups
Age, Continuous	64.00 years STANDARD_DEVIATION 10.36 • n=5 Participants	63.93 years STANDARD_DEVIATION 11.55 • n=7 Participants	63.96 years STANDARD_DEVIATION 10.90 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	28 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 days

Resolution of delirium as defined by 2 consecutive negative CAM-ICU assessments. The Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU assesses the four features of delirium: feature 1 is an acute change in mental status or a fluctuating mental status, feature 2 is inattention, feature 3 is altered level of consciousness, and feature 4 is disorganized thinking.

Outcome measures

Outcome measures
Measure	Infusion of Dexmedetomidine n=25 Participants infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of Care n=28 Participants Standard of Care Per treating attending physician preference
Resolution of Delirium	21 Participants	14 Participants

SECONDARY outcome

Timeframe: Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end

Number of days on mechanical ventilation

Outcome measures

Outcome measures
Measure	Infusion of Dexmedetomidine n=25 Participants infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of Care n=28 Participants Standard of Care Per treating attending physician preference
Length of Ventilator Support	1 days Interval 0.0 to 4.0	2 days Interval 0.5 to 15.5

SECONDARY outcome

Timeframe: Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end

Number of days intensive care unit (ICU) stay

Outcome measures

Outcome measures
Measure	Infusion of Dexmedetomidine n=25 Participants infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of Care n=28 Participants Standard of Care Per treating attending physician preference
Length of Intensive Care Unit (ICU) Stay	7 days Interval 5.0 to 11.0	7.5 days Interval 5.0 to 19.0

SECONDARY outcome

Timeframe: Up to initial 48 hours

Subjective measure rating 3 categories for ease of management: 1. Mostly easy 2. Easy to manage 75% of the time 3. Not easy to manage

Outcome measures

Outcome measures
Measure	Infusion of Dexmedetomidine n=25 Participants infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of Care n=28 Participants Standard of Care Per treating attending physician preference
Ease of Management for the Nursing Staff Mostly easy	16 Participants	7 Participants
Ease of Management for the Nursing Staff Easy to manage 75% of the time	4 Participants	2 Participants
Ease of Management for the Nursing Staff Not easy to manage	5 Participants	19 Participants

SECONDARY outcome

Timeframe: Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end

Did patient die while in the hospital? (Yes/No)

Outcome measures

Outcome measures
Measure	Infusion of Dexmedetomidine n=25 Participants infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect	Standard of Care n=28 Participants Standard of Care Per treating attending physician preference
In-hospital Mortality Yes, died	1 Participants	5 Participants
In-hospital Mortality No, did not die	24 Participants	23 Participants

Adverse Events

Infusion of Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gerald Weinhouse

BrighamHospital

Phone: 617-732-5499

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place