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

Critical Illness Clinical Trial

Official title:

A Double-blinded Randomized Controlled Trial of Dexmedetomidine Versus Propofol for Sedation in Mechanically Ventilated Medical Intensive Care Unit Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01059929
• Other study ID #: 16865B
• Status: Terminated
• Phase: Phase 4
• Start date: September 2009
• Est. completion date: September 2015

Study information

• Verified date: July 2018
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation

Intervention

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

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

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Hospira, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

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