Status:
COMPLETED
Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Delirium
Agitation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Dexmed...
Eligibility Criteria
Inclusion
- Adults admitted to our surgical ICU who do not have any exclusion criteria
- Eligibility for treatment- Development of delirium as defined
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00351299
Start Date
January 1 2006
End Date
October 1 2012
Last Update
June 9 2017
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02118