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Completed

NCT Number: NCT00351299

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexmedetomidine

Drug

dexmedetomidine infusion titrated to effect

Other names: Precedex

Standard of care

Other

Standard of care per treating physician preference

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Ease of Management for the Nursing Staff

    Time frame: Up to initial 48 hours

    Subjective measure rating 3 categories for ease of management:

    • Mostly easy
    • Easy to manage 75% of the time
    • Not easy to manage
  4. 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)

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Jul 12, 2006
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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