ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01059929
Recruitment Status : Terminated (drug and placebo unavailable)
First Posted : February 1, 2010
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Chicago

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.

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

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 : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : September 2009
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 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: 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 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




Primary Outcome Measures :
  1. Proportion of Days With Delirium [ Time Frame: daily up to 28 days ]
    delirium assessment using CAM-ICU


Secondary Outcome Measures :
  1. Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score [ Time Frame: Daily up to day 28 ]
    Richmond Agitation Sedation Scale (RASS). This is a validated scale that measures level of sedation. The scale ranges from -5 to +4. -5 refers to a state where one is unarousable, +4 refers to a state where one is combative. The median and inter-quartile range over all daily assessments will be provided.

  2. Number of Patients Completing Mobility Milestones [ Time Frame: Daily through day 28 ]
    Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently

  3. Days on Ventilator [ Time Frame: 60 days from enrollment ]
  4. Days in ICU [ Time Frame: 60 days from enollment ]
  5. Mortality [ Time Frame: 28 days from enrollment ]
  6. Number of Participants With ICU Complications [ Time Frame: daily through day 28 ]
  7. Number of Patients Requiring Fentanyl [ Time Frame: during infusion of study medication up to day 28 ]
  8. Number of Patients Requiring Midazolam [ Time Frame: during infusion of study medication through day 28 ]
  9. Days in Hospital [ Time Frame: 60 days from enrollment ]
  10. Number of Patients Completing Activities of Daily Living [ Time Frame: daily through day 28 ]
    activities of daily living: eating, bathing, dressing, grooming, toileting

  11. Number of Adverse Medication Effects [ Time Frame: duration of infusion of study medication up to 28 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059929


Locations
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: John P Kress, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01059929     History of Changes
Other Study ID Numbers: 16865B
First Posted: February 1, 2010    Key Record Dates
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Propofol
Dexmedetomidine
Midazolam
Fentanyl
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators