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

Primary Purpose

Mechanical Ventilation, Critical Illness

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Propofol
Fentanyl
Midazolam
Physical and Occupational Therapy
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Ventilation focused on measuring Hypnotics and Sedatives, Respiration, Artificial, Ventilators, Mechanical, Critical care, Intensive care, Physical therapy, Occupational therapy, Sedative medications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The University of Chicago Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dexmedetomidine

Propofol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of Days With Delirium
delirium assessment using CAM-ICU

Secondary Outcome Measures

Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score
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.
Number of Patients Completing Mobility Milestones
Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently
Days on Ventilator
Days in ICU
Mortality
Number of Participants With ICU Complications
Number of Patients Requiring Fentanyl
Number of Patients Requiring Midazolam
Days in Hospital
Number of Patients Completing Activities of Daily Living
activities of daily living: eating, bathing, dressing, grooming, toileting
Number of Adverse Medication Effects

Full Information

First Posted
September 14, 2009
Last Updated
July 2, 2018
Sponsor
University of Chicago
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01059929
Brief Title
Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)
Official Title
A Double-blinded Randomized Controlled Trial of Dexmedetomidine Versus Propofol for Sedation in Mechanically Ventilated Medical Intensive Care Unit Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
drug and placebo unavailable
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation, Critical Illness
Keywords
Hypnotics and Sedatives, Respiration, Artificial, Ventilators, Mechanical, Critical care, Intensive care, Physical therapy, Occupational therapy, Sedative medications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed
Intervention Description
0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)
Intervention Type
Behavioral
Intervention Name(s)
Physical and Occupational Therapy
Intervention Description
Daily therapy sessions targeting range of motion, strength, and mobility
Primary Outcome Measure Information:
Title
Proportion of Days With Delirium
Description
delirium assessment using CAM-ICU
Time Frame
daily up to 28 days
Secondary Outcome Measure Information:
Title
Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score
Description
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.
Time Frame
Daily up to day 28
Title
Number of Patients Completing Mobility Milestones
Description
Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently
Time Frame
Daily through day 28
Title
Days on Ventilator
Time Frame
60 days from enrollment
Title
Days in ICU
Time Frame
60 days from enollment
Title
Mortality
Time Frame
28 days from enrollment
Title
Number of Participants With ICU Complications
Time Frame
daily through day 28
Title
Number of Patients Requiring Fentanyl
Time Frame
during infusion of study medication up to day 28
Title
Number of Patients Requiring Midazolam
Time Frame
during infusion of study medication through day 28
Title
Days in Hospital
Time Frame
60 days from enrollment
Title
Number of Patients Completing Activities of Daily Living
Description
activities of daily living: eating, bathing, dressing, grooming, toileting
Time Frame
daily through day 28
Title
Number of Adverse Medication Effects
Time Frame
duration of infusion of study medication up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Kress, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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