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

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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Mechanical Ventilation
Critical Illness
Interventions: Drug: Dexmedetomidine
Drug: Propofol
Drug: Fentanyl
Drug: Midazolam
Behavioral: Physical and Occupational Therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

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.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility


Participant Flow:   Overall Study
    Dexmedetomidine   Propofol
STARTED   20   21 
COMPLETED   20   21 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

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.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Total Total of all reporting groups

Baseline Measures
   Dexmedetomidine   Propofol   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   21   41 
Age 
[Units: Years]
Mean (Full Range)
 60.5 
 (33 to 87) 
 67 
 (21 to 89) 
 63.8 
 (21 to 89) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  55.0%      9  42.9%      20  48.8% 
Male      9  45.0%      12  57.1%      21  51.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   5.0%      0   0.0%      1   2.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      8  40.0%      11  52.4%      19  46.3% 
White      11  55.0%      10  47.6%      21  51.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Proportion of Days With Delirium   [ Time Frame: daily up to 28 days ]

2.  Secondary:   Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score   [ Time Frame: Daily up to day 28 ]

3.  Secondary:   Number of Patients Completing Mobility Milestones   [ Time Frame: Daily through day 28 ]

4.  Secondary:   Days on Ventilator   [ Time Frame: 60 days from enrollment ]

5.  Secondary:   Days in ICU   [ Time Frame: 60 days from enollment ]

6.  Secondary:   Mortality   [ Time Frame: 28 days from enrollment ]

7.  Secondary:   Number of Participants With ICU Complications   [ Time Frame: daily through day 28 ]

8.  Secondary:   Number of Patients Requiring Fentanyl   [ Time Frame: during infusion of study medication up to day 28 ]

9.  Secondary:   Number of Patients Requiring Midazolam   [ Time Frame: during infusion of study medication through day 28 ]

10.  Secondary:   Days in Hospital   [ Time Frame: 60 days from enrollment ]

11.  Secondary:   Number of Patients Completing Activities of Daily Living   [ Time Frame: daily through day 28 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John Kress
Organization: University of Chicago
phone: 773-702-6790
e-mail: jkress@medicine.bsd.uchicago.edu



Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01059929     History of Changes
Other Study ID Numbers: 16865B
First Submitted: September 14, 2009
First Posted: February 1, 2010
Results First Submitted: November 1, 2016
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018