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

Phase 4

Terminated

Conditions: Critical Illness
Mechanical Ventilation

Interventions: Drug: Dexmedetomidine
Drug: Propofol
Drug: Fentanyl
Drug: Midazolam
Behavioral: Physical and Occupational Therapy

Registration Number: NCT01059929

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 41

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Physical and Occupational Therapy	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.
Propofol	Physical and Occupational Therapy	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.
Dexmedetomidine	Midazolam	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	Fentanyl	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	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.
Propofol	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	Fentanyl	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	Midazolam	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Days With Delirium	daily up to 28 days	delirium assessment using CAM-ICU

Secondary Outcome Measures

Name	Time	Method
Number of Patients Requiring Fentanyl	during infusion of study medication up to day 28
Number of Adverse Medication Effects	duration of infusion of study medication up to 28 days
Mortality	28 days from enrollment
Number of Participants With ICU Complications	daily through day 28
Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score	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.
Number of Patients Completing Mobility Milestones	Daily through day 28	Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently
Days on Ventilator	60 days from enrollment
Days in ICU	60 days from enollment
Days in Hospital	60 days from enrollment
Number of Patients Requiring Midazolam	during infusion of study medication through day 28
Number of Patients Completing Activities of Daily Living	daily through day 28	activities of daily living: eating, bathing, dressing, grooming, toileting