Trial Outcomes & Findings for Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU) (NCT NCT01059929)

NCT ID: NCT01059929

Last Updated: 2018-07-03

Results Overview

delirium assessment using CAM-ICU

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 41 participants
• Primary outcome timeframe: daily up to 28 days
• Results posted on: 2018-07-03

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	20	21
Overall Study COMPLETED	20	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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 n=41 Participants Total of all reporting groups
Age, Continuous	60.5 years n=5 Participants	67 years n=7 Participants	63.8 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: daily up to 28 days

Population: Study terminated early due to inability to maintain study drug supply in investigational pharmacy.

delirium assessment using CAM-ICU

Outcome measures

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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
Proportion of Days With Delirium	0 proportion of days Interval 0.0 to 0.71	.33 proportion of days Interval 0.13 to 0.71

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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
Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score	-1 score on a scale Interval -1.0 to -0.57	-1.6 score on a scale Interval -3.23 to -1.0

SECONDARY outcome

Timeframe: Daily through day 28

Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently

Outcome measures

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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
Number of Patients Completing Mobility Milestones	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 60 days from enrollment

Outcome measures

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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
Days on Ventilator	3.85 days Interval 2.28 to 16.6	4.05 days Interval 2.54 to 11.49

SECONDARY outcome

Timeframe: 60 days from enollment

Outcome measures

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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
Days in ICU	6.39 days Interval 3.64 to 17.6	5.61 days Interval 2.88 to 11.22

SECONDARY outcome

Timeframe: 28 days from enrollment

Outcome measures

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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
Mortality	8 Participants	12 Participants

SECONDARY outcome

Timeframe: daily through day 28

Outcome measures

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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
Number of Participants With ICU Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: during infusion of study medication up to day 28

Outcome measures

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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
Number of Patients Requiring Fentanyl	3 Participants	6 Participants

SECONDARY outcome

Timeframe: during infusion of study medication through day 28

Outcome measures

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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
Number of Patients Requiring Midazolam	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 60 days from enrollment

Outcome measures

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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
Days in Hospital	14.33 days Interval 6.3 to 32.39	12.96 days Interval 4.83 to 20.82

SECONDARY outcome

Timeframe: daily through day 28

activities of daily living: eating, bathing, dressing, grooming, toileting

Outcome measures

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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
Number of Patients Completing Activities of Daily Living	7 Participants	6 Participants

SECONDARY outcome

Timeframe: duration of infusion of study medication up to 28 days

Outcome measures

Measure	Dexmedetomidine n=20 Participants 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 n=21 Participants 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
Number of Adverse Medication Effects	0 number of events	0 number of events

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Kress

University of Chicago

Phone: 773-702-6790

Email: jkress@medicine.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place