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

NCT01059929

Last updated date
Study Location
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mechanical Ventilation, Critical Illness
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- >18 years old

- mechanically ventilated through endotracheal tube

- anticipated need for ventilation > 48 hours

- requiring sedative/analgesic medication

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Mechanical Ventilation, Critical IllnessDexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)
NCT01059929
  1. Chicago, Illinois
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)
Official Title  ICMJE A Double-blinded Randomized Controlled Trial of Dexmedetomidine Versus Propofol for Sedation in Mechanically Ventilated Medical Intensive Care Unit Patients.
Brief Summary This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (> 24 hours) in critically ill patients who require mechanical ventilation.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mechanical Ventilation
  • Critical Illness
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 2, 2018)
41
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2010)
210
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01059929
Other Study ID Numbers  ICMJE 16865B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:John P Kress, MDUniversity of Chicago
PRS Account University of Chicago
Verification Date July 2018

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