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

NCT01059929 | Terminated Phase 4 Results DMC

• 1 other identifier: 16865B
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Critical Illness

Keywords

Hypnotics and Sedatives; Respiration, Artificial; Ventilators, Mechanical; Critical care; Intensive care; Physical therapy; Occupational therapy; Sedative medications

Outcome Measures

Primary Outcomes (1)

• Proportion of Days With Delirium

  delirium assessment using CAM-ICU

  daily up to 28 days

Secondary Outcomes (11)

• Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score

  Daily up to day 28

• Number of Patients Completing Mobility Milestones

  Daily through day 28

• Days on Ventilator

  60 days from enrollment

• Days in ICU

  60 days from enollment

• Mortality

  28 days from enrollment

Study Arms (2)

Dexmedetomidine

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.

Drug: Dexmedetomidine; Drug: Fentanyl; Drug: Midazolam; Behavioral: Physical and Occupational Therapy

Propofol

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.

Drug: Propofol; Drug: Fentanyl; Drug: Midazolam; Behavioral: Physical and Occupational Therapy

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Dexmedetomidine

Propofol DRUG

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

Also known as: Diprivan

Propofol

Fentanyl DRUG

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

Dexmedetomidine; Propofol

Midazolam DRUG

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

Also known as: Versed

Dexmedetomidine; Propofol

Physical and Occupational Therapy BEHAVIORAL

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

Dexmedetomidine; Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old
• mechanically ventilated through endotracheal tube
• anticipated need for ventilation \> 48 hours
• requiring sedative/analgesic medication

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Critical Illness; Respiratory Aspiration

Interventions

Dexmedetomidine; Propofol; Fentanyl; Midazolam; Restraint, Physical; Occupational Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Results Point of Contact

• Title: John Kress
• Organization: University of Chicago

jkress@medicine.bsd.uchicago.edu

773-702-6790

Study Officials

• John P Kress, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: February 1, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 3, 2018
• Results First Posted: July 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)