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

Phase 2

Completed

• Conditions: Delirium; Agitation
• Interventions: Other: Standard of Care; Drug: Dexmedetomidine

• Registration Number: NCT00351299
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-07-10
• Study First Submitted QC: 2006-07-10
• Study First Posted: 2006-07-12
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2017-03-29
• Results First Submitted QC: 2017-03-29
• Status Verified: 2017-05
• Results First Posted: 2017-05-09
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Adults admitted to our surgical ICU who do not have any exclusion criteria
• Eligibility for treatment- Development of delirium as defined

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Standard of care per treating physician preference
Infusion of dexmedetomidine	Dexmedetomidine	infusion 0.3-0.7 dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Resolution of Delirium	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 Outcome Measures

Name	Time	Method
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	Did patient die while in the hospital? (Yes/No)
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	Number of days on mechanical ventilation
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	Number of days intensive care unit (ICU) stay
Ease of Management for the Nursing Staff	Up to initial 48 hours	Subjective measure rating 3 categories for ease of management: 1. Mostly easy; 2. Easy to manage 75% of the time; 3. Not easy to manage

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States