Agitation, Delirium
Conditions
Keywords
Delirium, Agitation, Sedation, Dexmedetomidine, Surgical
Brief summary
The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect - a sedative) is effective for the treatment of acute delirium
Detailed description
Delirium is a mental disturbance that causes people to be confused and restless for a period of time. We will compare dexmedetomidine to the traditional therapy for treatment of acute delirium. Dexmedetomidine does not affect breathing. The traditional drugs might make one sleepy and may slow down breathing. The traditional therapy in this institution for acute delirium is \_the use of Haloperidol, and/or benzodiazepines. Haloperidol is an antipsychotic drug that has calming effect. Benzodiazepines are sedatives with calming effect.Dexmedetomidine is approved by the Food and drug Administration (FDA) to sedate patients on a breathing machine for 24 hours.
Interventions
DRUGDexmedetomidine
dexmedetomidine infusion titrated to effect
OTHERStandard of Care
Standard of care per treating physician preference
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults admitted to our surgical ICU who do not have any
Exclusion criteria
* Eligibility for treatment- Development of delirium as defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Delirium | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Ventilator Support | 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 |
| Length of Intensive Care Unit (ICU) Stay | 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 |
| Ease of Management for the Nursing Staff | 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 |
| In-hospital Mortality | 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) |
Countries
United States
Participant flow
Recruitment details
Patients admitted to ICU from 2005-2008
Pre-assignment details
Patients enrolled and randomized upon admission to ICU but treated with dexmedetomidine or standard of caremodalities only if they developed delirium.
Participants by arm
| Arm | Count |
|---|---|
| Infusion of Dexmedetomidine infusion 0.3-0.7 dexmedetomidine
Dexmedetomidine: dexmedetomidine infusion titrated to effect | 25 |
| Standard of Care Standard of care per treating physician preference | 28 |
| Total | 53 |
Baseline characteristics
| Characteristic | Infusion of Dexmedetomidine | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 64.00 years STANDARD_DEVIATION 10.36 | 63.93 years STANDARD_DEVIATION 11.55 | 63.96 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment United States | 25 participants | 28 participants | 53 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 17 Participants | 21 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 28 |
| serious Total, serious adverse events | 0 / 25 | 0 / 28 |
Outcome results
Primary
Resolution of Delirium
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.
Time frame: Up to 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infusion of Dexmedetomidine | Resolution of Delirium | 21 Participants |
| Standard of Care | Resolution of Delirium | 14 Participants |
Secondary
Ease of Management for the Nursing Staff
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
Time frame: Up to initial 48 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infusion of Dexmedetomidine | Ease of Management for the Nursing Staff | Mostly easy | 16 Participants |
| Infusion of Dexmedetomidine | Ease of Management for the Nursing Staff | Easy to manage 75% of the time | 4 Participants |
| Infusion of Dexmedetomidine | Ease of Management for the Nursing Staff | Not easy to manage | 5 Participants |
| Standard of Care | Ease of Management for the Nursing Staff | Mostly easy | 7 Participants |
| Standard of Care | Ease of Management for the Nursing Staff | Easy to manage 75% of the time | 2 Participants |
| Standard of Care | Ease of Management for the Nursing Staff | Not easy to manage | 19 Participants |
Secondary
In-hospital Mortality
Did patient die while in the hospital? (Yes/No)
Time frame: 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infusion of Dexmedetomidine | In-hospital Mortality | Yes, died | 1 Participants |
| Infusion of Dexmedetomidine | In-hospital Mortality | No, did not die | 24 Participants |
| Standard of Care | In-hospital Mortality | No, did not die | 23 Participants |
| Standard of Care | In-hospital Mortality | Yes, died | 5 Participants |
Secondary
Length of Intensive Care Unit (ICU) Stay
Number of days intensive care unit (ICU) stay
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Infusion of Dexmedetomidine | Length of Intensive Care Unit (ICU) Stay | 7 days |
| Standard of Care | Length of Intensive Care Unit (ICU) Stay | 7.5 days |
Secondary
Length of Ventilator Support
Number of days on mechanical ventilation
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Infusion of Dexmedetomidine | Length of Ventilator Support | 1 days |
| Standard of Care | Length of Ventilator Support | 2 days |