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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infusion of dexmedetomidine | Experimental | infusion 0.3-0.7 dexmedetomidine |
|
| Standard of Care | Other | Standard of care per treating physician preference |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | dexmedetomidine infusion titrated to effect |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Ventilator Support | Number of days on mechanical ventilation | 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 |
| Length of Intensive Care Unit (ICU) Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald L Weinhouse, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02118 | United States |
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Patients enrolled and randomized upon admission to ICU but treated with dexmedetomidine or standard of caremodalities only if they developed delirium.
Patients admitted to ICU from 2005-2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Infusion of Dexmedetomidine | infusion 0.2-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect |
| FG001 | Standard of Care | Standard of care per treating physician preference |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infusion of Dexmedetomidine | infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect |
| BG001 | Standard of Care | Standard of care per treating physician preference |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 7 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infusion of Dexmedetomidine | infusion 0.3-0.7 dexmedetomidine Dexmedetomidine: dexmedetomidine infusion titrated to effect |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gerald Weinhouse | BrighamHospital | 617-732-5499 | gweinhouse@partners.org |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Standard of Care | Other | Standard of care per treating physician preference |
|
Number of days 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 |
| Ease of Management for the Nursing Staff | Subjective measure rating 3 categories for ease of management:
| Up to initial 48 hours |
| In-hospital Mortality | Did patient die while in the hospital? (Yes/No) | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Length of Ventilator Support | Number of days on mechanical ventilation | Posted | Median | Inter-Quartile Range | days | 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 |
|
|
|
| Secondary | Length of Intensive Care Unit (ICU) Stay | Number of days intensive care unit (ICU) stay | Posted | Median | Inter-Quartile Range | days | 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 |
|
|
|
| Secondary | Ease of Management for the Nursing Staff | Subjective measure rating 3 categories for ease of management:
| Posted | Count of Participants | Participants | Up to initial 48 hours |
|
|
|
| Secondary | In-hospital Mortality | Did patient die while in the hospital? (Yes/No) | Posted | Count of Participants | Participants | 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 |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Standard of Care | Standard of care per treating physician preference | 0 | 28 | 0 | 28 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D011596 | Psychomotor Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| Not easy to manage |
|