Clinical trial NCT01059929: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Mechanical Ventilation
Critical Illness
Keywords: Hypnotics and Sedatives
Respiration, Artificial
Ventilators, Mechanical
Critical care
Intensive care
Physical therapy
Occupational therapy
Sedative medications
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2010-02-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Proportion of Days With Delirium
timeFrame: daily up to 28 days
Secondary outcomes:
measure: Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score
timeFrame: Daily up to day 28
measure: Number of Patients Completing Mobility Milestones
timeFrame: Daily through day 28
measure: Days on Ventilator
timeFrame: 60 days from enrollment
measure: Days in ICU
timeFrame: 60 days from enollment
measure: Mortality
timeFrame: 28 days from enrollment
measure: Number of Participants With ICU Complications
timeFrame: daily through day 28
measure: Number of Patients Requiring Fentanyl
timeFrame: during infusion of study medication up to day 28
measure: Number of Patients Requiring Midazolam
timeFrame: during infusion of study medication through day 28
measure: Days in Hospital
timeFrame: 60 days from enrollment
measure: Number of Patients Completing Activities of Daily Living
timeFrame: daily through day 28
measure: Number of Adverse Medication Effects
timeFrame: duration of infusion of study medication up to 28 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: John P Kress, MD
role: PRINCIPAL_INVESTIGATOR
References: