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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
Information provided by:
Brigham and Women's Hospital Identifier:
First received: July 10, 2006
Last updated: May 3, 2010
Last verified: May 2010
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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
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 Brigham and Women's Hospital:

Primary Outcome Measures:
  • Resolution of delirium as defined

Secondary Outcome Measures:
  • Decreased length of ventilator support
  • Decreased length of ICU stay
  • Decreased need for additional sedatives.
  • Easier to manage for the nursing staff
  • Decreased hospital stay
  • Decreased in-hospital mortality.

Estimated Enrollment: 130
Study Start Date: January 2006
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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,
  • Trauma <24 hours,
  • Head injury,
  • Multiple organ failure,
  • EF < 30%,
  • History of hypersensitivity to alpha2 agonist,
  • History of seizures, MAP<60 mm of Hg,
  • Dysrhythmias a/with bradycardia (HR <50),
  • Need for vasopressors,
  • Acute renal failure with a need for dialysis/CVVH 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, MD, Brigham & Women's Hospital Identifier: NCT00351299     History of Changes
Other Study ID Numbers: 2005-P-001786, BWH
Study First Received: July 10, 2006
Last Updated: May 3, 2010

Keywords provided by 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 April 21, 2017