Overview

This trial is active, not recruiting.

Conditions mechanical ventilation, critical illness
Treatments dexmedetomidine, propofol, fentanyl, midazolam, physical and occupational therapy
Phase phase 4
Sponsor University of Chicago
Collaborator Hospira, Inc.
Start date September 2009
End date September 2015
Trial size 210 participants
Trial identifier NCT01059929, 16865B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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 Precedex
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 Versed
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
(Active Comparator)
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 Diprivan
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 Versed
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

Primary Outcomes

Measure
Delirium
time frame: Daily

Secondary Outcomes

Measure
Drug Efficacy
time frame: Daily
Mobility milestones
time frame: Daily
Days on ventilator
time frame: 28 days from enrollment
Days in ICU
time frame: 28 days from enollment
Mortality
time frame: 28 days from enrollment
ICU complications
time frame: Duration of ICU admission
Fentanyl requirement
time frame: During infusion of study medication
Midazolam requirement
time frame: During infusion of study medication
Days in Hospital
time frame: 28 days from enrollment
Activities of daily living
time frame: Up to 1 year from enrollment
Adverse medication effects
time frame: During infusion of study medication

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title A Double-blinded Randomized Controlled Trial of Dexmedetomidine Versus Propofol for Sedation in Mechanically Ventilated Medical Intensive Care Unit Patients.
Principal investigator John P Kress, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Chicago.