Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium
This trial is active, not recruiting.
|Conditions||delirium, agitation, sedation|
|Sponsor||Brigham and Women's Hospital|
|Start date||January 2006|
|End date||February 2011|
|Trial size||130 participants|
|Trial identifier||NCT00351299, 2005-P-001786, BWH|
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
|Endpoint classification||safety/efficacy study|
|Intervention model||factorial assignment|
Resolution of delirium as defined
Decreased length of ventilator support
Decreased length of ICU stay
Decreased need for additional sedatives.
Easier to manage for the nursing staff
Decreased hospital stay
Decreased in-hospital mortality.
Male or female participants at least 18 years old.
- Adults admitted to our surgical ICU who do not have any exclusion criteria
- Eligibility for treatment- Development of delirium as defined
- 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)
|Official title||Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium|
|Principal investigator||Gerald L Weinhouse, MD|
|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.|
Call for more information