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

Brigham and Women's Hospital53 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Delirium Agitation

Interventions

DexmedetomidineDRUG

dexmedetomidine infusion titrated to effect

Standard of CareOTHER

Standard of care per treating physician preference

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 7 days

Secondary Outcomes

Length of Ventilator Support

Number of days on mechanical ventilation

Time frame: 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

Time frame: 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: 1. Mostly easy 2. Easy to manage 75% of the time 3. Not easy to manage

Time frame: Up to initial 48 hours

In-hospital Mortality

Did patient die while in the hospital? (Yes/No)

Time frame: 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

Data from ClinicalTrials.gov

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