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

This study has been completed.
Information provided by (Responsible Party):
Gerald L. Weinhouse, Brigham and Women's Hospital Identifier:
First received: July 10, 2006
Last updated: March 29, 2017
Last verified: March 2017
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

Condition Intervention Phase
Drug: Dexmedetomidine
Other: Standard of Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium

Resource links provided by NLM:

Further study details as provided by Gerald L. Weinhouse, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Length of Ventilator Support [ Time Frame: Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier ]
    Number of days on mechanical ventilation

  • Length of 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 ]
    Number of days intensive care unit (ICU) stay

  • Ease of Management for the Nursing Staff [ Time Frame: 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

  • In-hospital Mortality [ Time Frame: Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier. ]
    Did patient die while in the hospital? (Yes/No)

Enrollment: 134
Study Start Date: January 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infusion of dexmedetomidine
infusion 0.3-0.7 dexmedetomidine
Drug: Dexmedetomidine
dexmedetomidine infusion titrated to effect
Other Name: Precedex
Standard of Care
Standard of care per treating physician preference
Other: Standard of Care
Standard of care per treating physician preference

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00351299

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Gerald L Weinhouse, MD Brigham and Women's Hospital
  More Information

Responsible Party: Gerald L. Weinhouse, Staff Physician, Brigham and Women's Hospital Identifier: NCT00351299     History of Changes
Other Study ID Numbers: 2005-P-001786, BWH
Study First Received: July 10, 2006
Results First Received: March 29, 2017
Last Updated: March 29, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Gerald L. Weinhouse, Brigham and Women's Hospital:

Additional relevant MeSH terms:
Psychomotor Agitation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Psychomotor Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017