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

This study is currently recruiting participants.
Verified January 2013 by University of Chicago
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
John Kress, University of Chicago
ClinicalTrials.gov Identifier:
NCT01059929
First received: September 14, 2009
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (> 24 hours) in critically ill patients who require mechanical ventilation.


Condition Intervention Phase
Mechanical Ventilation
Critical Illness
 Drug: Dexmedetomidine
Drug: Propofol
Drug: Fentanyl
Drug: Midazolam
Behavioral: Physical and Occupational Therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blinded Randomized Controlled Trial of Dexmedetomidine Versus Propofol for Sedation in Mechanically Ventilated Medical Intensive Care Unit Patients.

Resource links provided by NLM:

MedlinePlus related topics: Critical Care
U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Delirium [ Time Frame: Daily ] [ Designated as safety issue: No ]
    CAM-ICU assessment


Secondary Outcome Measures:
  • Drug Efficacy [ Time Frame: Daily ] [ Designated as safety issue: No ]
    Richmond Agitation Sedation Scale (RASS)

  • Mobility milestones [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Days on ventilator [ Time Frame: 28 days from enrollment ] [ Designated as safety issue: No ]
  • Days in ICU [ Time Frame: 28 days from enollment ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 28 days from enrollment ] [ Designated as safety issue: No ]
  • ICU complications [ Time Frame: Duration of ICU admission ] [ Designated as safety issue: No ]
  • Fentanyl requirement [ Time Frame: During infusion of study medication ] [ Designated as safety issue: No ]
  • Midazolam requirement [ Time Frame: During infusion of study medication ] [ Designated as safety issue: No ]
  • Days in Hospital [ Time Frame: 28 days from enrollment ] [ Designated as safety issue: No ]
  • Activities of daily living [ Time Frame: Up to 1 year from enrollment ] [ Designated as safety issue: No ]
  • Adverse medication effects [ Time Frame: During infusion of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: September 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Dexmedetomidine
continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS
Other Name: Precedex
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 IVpush 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: 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.
 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 IVpush 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

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.

  Eligibility

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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059929

Contacts
Contact: Anne S Pohlman 773-702-3804 apohlman@medicince.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: John P Kress, MD     773-702-6404     jkress@medicine.bsd.uchicago.edu    
Sponsors and Collaborators
University of Chicago
Hospira, Inc.
Investigators
Principal Investigator: John P Kress, MD University of Chicago
  More Information

No publications provided

Responsible Party: John Kress, Associate Prof of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT01059929     History of Changes
Other Study ID Numbers: 16865B
Study First Received: September 14, 2009
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Hypnotics and Sedatives
Respiration, Artificial
Ventilators, Mechanical
Critical care
 Intensive care
Physical therapy
Occupational therapy
Sedative medications

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Midazolam
Fentanyl
Hypnotics and Sedatives
Propofol
Dexmedetomidine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on May 16, 2013