Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium

Conditions
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Delirium, Agitation

Intervention / Treatment
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* Drug: Dexmedetomidine
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infusion of dexmedetomidine<br>infusion 0.3-0.7 dexmedetomidine | Drug: Dexmedetomidine<br>* dexmedetomidine infusion titrated to effect<br>* Other names: Precedex;|
| Other: Standard of Care<br>Standard of care per treating physician preference | Other: Standard of Care<br>* Standard of care per treating physician preference<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Delirium | 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. | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Ventilator Support | Number of days on mechanical ventilation | 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 | Number of days 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 | Subjective measure rating 3 categories for ease of management: Mostly easy Easy to manage 75% of the time Not easy to manage | Up to initial 48 hours | 
| In-hospital Mortality | Did patient die while in the hospital? (Yes/No) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Agitation, Sedation, Dexmedetomidine, Surgical