Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium
Overview
- Phase
- Phase 2
- Intervention
- Dexmedetomidine
- Conditions
- Delirium
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Resolution of Delirium
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Gerald L. Weinhouse
Staff Physician
Brigham and Women's Hospital
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.
Arms & Interventions
Infusion of dexmedetomidine
infusion 0.3-0.7 dexmedetomidine
Intervention: Dexmedetomidine
Standard of Care
Standard of care per treating physician preference
Intervention: Standard of Care
Outcomes
Primary Outcomes
Resolution of Delirium
Time Frame: Up to 7 days
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.
Secondary Outcomes
- In-hospital Mortality(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 Ventilator Support(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(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(Up to initial 48 hours)