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

NCT ID: NCT01059929

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Mechanical Ventilation; Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl

Intervention Type: DRUG

25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam

Intervention Type: DRUG

0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS\>+2)

Physical and Occupational Therapy

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl

Intervention Type: DRUG

25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam

Intervention Type: DRUG

0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS\>+2)

Physical and Occupational Therapy

Intervention Type: BEHAVIORAL

Daily therapy sessions targeting range of motion, strength, and mobility

Interventions

Dexmedetomidine

continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Intervention Type: DRUG

Propofol

continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Intervention Type: DRUG

Fentanyl

25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Intervention Type: DRUG

Midazolam

0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS\>+2)

Intervention Type: DRUG

Physical and Occupational Therapy

Daily therapy sessions targeting range of motion, strength, and mobility

Intervention Type: BEHAVIORAL

Other Intervention Names

Precedex; Diprivan; Versed

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John P Kress, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

16865B

Identifier Type: -

Identifier Source: org_study_id