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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Brigham and Women's Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00351299
First received: July 10, 2006
Last updated: May 3, 2010
Last verified: May 2010
  Purpose

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
Delirium
Agitation
Sedation
Drug: Dexmedetomidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00351299

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

No publications provided

Responsible Party: Gerald L. Weinhouse, MD, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT00351299     History of Changes
Other Study ID Numbers: 2005-P-001786, BWH
Study First Received: July 10, 2006
Last Updated: May 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Delirium
Agitation
Sedation
Dexmedetomidine
Surgical

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on September 16, 2014