This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerald L. Weinhouse, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00351299
First received: July 10, 2006
Last updated: May 9, 2017
Last verified: May 2017
  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 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, up to study end ]
    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, up to study end ]
    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, up to study end ]
    Did patient die while in the hospital? (Yes/No)


Enrollment: 53
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 (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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Gerald L. Weinhouse, Staff Physician, Brigham and Women's Hospital
ClinicalTrials.gov 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: May 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Gerald L. Weinhouse, Brigham and Women's Hospital:
Delirium
Agitation
Sedation
Dexmedetomidine
Surgical

Additional relevant MeSH terms:
Delirium
Psychomotor Agitation
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Psychomotor Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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 July 25, 2017