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Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)

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ClinicalTrials.gov Identifier: NCT01059929
Recruitment Status : Unknown
Verified December 2014 by University of Chicago.
Recruitment status was:  Active, not recruiting
First Posted : February 1, 2010
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Chicago

September 14, 2009
February 1, 2010
December 3, 2014
September 2009
September 2015   (Final data collection date for primary outcome measure)
Delirium [ Time Frame: Daily ]
CAM-ICU assessment
Delirium [ Time Frame: Daily ]
Complete list of historical versions of study NCT01059929 on ClinicalTrials.gov Archive Site
  • Drug Efficacy [ Time Frame: Daily ]
    Richmond Agitation Sedation Scale (RASS)
  • Mobility milestones [ Time Frame: Daily ]
  • Days on ventilator [ Time Frame: 28 days from enrollment ]
  • Days in ICU [ Time Frame: 28 days from enollment ]
  • Mortality [ Time Frame: 28 days from enrollment ]
  • ICU complications [ Time Frame: Duration of ICU admission ]
  • Fentanyl requirement [ Time Frame: During infusion of study medication ]
  • Midazolam requirement [ Time Frame: During infusion of study medication ]
  • Days in Hospital [ Time Frame: 28 days from enrollment ]
  • Activities of daily living [ Time Frame: Up to 1 year from enrollment ]
  • Adverse medication effects [ Time Frame: During infusion of study medication ]
  • Drug Efficacy [ Time Frame: Daily ]
  • Mobility milestones [ Time Frame: Daily ]
  • Days on ventilator [ Time Frame: 28 days from enrollment ]
  • Days in ICU [ Time Frame: 28 days from enollment ]
  • Mortality [ Time Frame: 28 days from enrollment ]
  • ICU complications [ Time Frame: Duration of ICU admission ]
  • Fentanyl requirement [ Time Frame: During infusion of study medication ]
  • Midazolam requirement [ Time Frame: During infusion of study medication ]
  • Days in Hospital [ Time Frame: 28 days from enrollment ]
  • Activities of daily living [ Time Frame: Up to 1 year from enrollment ]
  • Adverse medication effects [ Time Frame: During infusion of study medication ]
Not Provided
Not Provided
 
Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)
A Double-blinded Randomized Controlled Trial of Dexmedetomidine Versus Propofol for Sedation in Mechanically Ventilated Medical Intensive Care Unit Patients.
This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (> 24 hours) in critically ill patients who require mechanical ventilation.
Mechanically ventilated critically ill patients are routinely given sedative and analgesic medications to relieve pain and anxiety associated with intubation, mechanical ventilation, and critical care in general. While integral in minimizing discomfort, these medications may increase mechanical ventilation time, the duration of intensive care unit (ICU) stay, ICU complications (e.g. delirium, ventilator associated pneumonia, venous thromboembolism), the morbidity associated with critical illness, and patient mortality. This study compares two sedative medications that have been used in patients who require a mechanical ventilator. Enrolled patients will be randomly assigned to receive propofol or dexmedetomidine for sedation while they require ventilatory support. All patients will also receive the pain medication fentanyl as needed.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Mechanical Ventilation
  • Critical Illness
  • Drug: Dexmedetomidine
    continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS
    Other Name: Precedex
  • Drug: Propofol
    continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS
    Other Name: Diprivan
  • Drug: Fentanyl
    25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale
  • Drug: Midazolam
    0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)
    Other Name: Versed
  • Behavioral: Physical and Occupational Therapy
    Daily therapy sessions targeting range of motion, strength, and mobility
  • Active Comparator: Dexmedetomidine
    Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Fentanyl
    • Drug: Midazolam
    • Behavioral: Physical and Occupational Therapy
  • Active Comparator: Propofol
    Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
    Interventions:
    • Drug: Propofol
    • Drug: Fentanyl
    • Drug: Midazolam
    • Behavioral: Physical and Occupational Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
210
Same as current
September 2015
September 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • >18 years old
  • mechanically ventilated through endotracheal tube
  • anticipated need for ventilation > 48 hours
  • requiring sedative/analgesic medication

Exclusion Criteria:

  • on mechanical ventilator > 96 hours
  • primary neurologic disease
  • post cardiac arrest
  • do not speak English (assessment only English language validated)
  • pregnancy or lactation
  • active myocardial ischemia
  • second or third degree heart block
  • pancreatitis
  • elevated serum triglycerides (> 400 mg/dL)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01059929
16865B
Yes
Not Provided
Not Provided
University of Chicago
University of Chicago
Hospira, now a wholly owned subsidiary of Pfizer
Principal Investigator: John P Kress, MD University of Chicago
University of Chicago
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP