Delirium Clinical Trial
Official title:
Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium
Verified date | May 2010 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 130 |
Est. completion date | September 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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, - Trauma <24 hours, - Head injury, - Multiple organ failure, - EF < 30%, - History of hypersensitivity to alpha2 agonist, - History of seizures, MAP<60 mm of Hg, - Dysrhythmias a/with bradycardia (HR <50), - Need for vasopressors, - Acute renal failure with a need for dialysis/CVVH 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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resolution of delirium as defined | |||
Secondary | Decreased length of ventilator support | |||
Secondary | Decreased length of ICU stay | |||
Secondary | Decreased need for additional sedatives. | |||
Secondary | Easier to manage for the nursing staff | |||
Secondary | Decreased hospital stay | |||
Secondary | Decreased in-hospital mortality. |
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