Clinical trial NCT00351299: Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium
Official title: Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delirium
Agitation
Keywords: Delirium
Agitation
Sedation
Dexmedetomidine
Surgical
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2006-07-12
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Adults admitted to our surgical ICU who do not have any exclusion criteria
* Eligibility for treatment- Development of delirium as defined

Exclusion Criteria:

* Acute MI (myocardial infarction),
* Trauma \<24 hours,
* Head injury,
* Multiple organ failure,
* EF (ejection fraction) \< 30%,
* History of hypersensitivity to alpha2 agonist,
* History of seizures, MAP (mean arterial pressure) \<60 mm of Hg,
* Dysrhythmias a/with bradycardia (HR (heart rate) \<50),
* Need for vasopressors,
* Acute renal failure with a need for dialysis/CVVH (Continuous Veno-Venous Hemofiltration) or liver disease.
* Women of child bearing age who do not have a documented negative pregnancy test and/or who do not actively use contraception. (Documented negative pregnancy test will be a urine pregnancy test obtained on this admission)

Primary outcomes:
measure: Resolution of Delirium
timeFrame: Up to 7 days
Secondary outcomes:
measure: Length of Ventilator Support
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
measure: Length of Intensive Care Unit (ICU) Stay
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
measure: Ease of Management for the Nursing Staff
timeFrame: Up to initial 48 hours
measure: In-hospital Mortality
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
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Gerald L Weinhouse, MD
role: PRINCIPAL_INVESTIGATOR
References: