Pilot Study Evaluating Stress Response and Immune Function in Mechanically Ventilated Patients With Alcohol Use Disorders Treated With Propofol or Midazolam
Phase 4
Withdrawn
- Conditions
- Respiration, ArtificialAlcoholism
- Interventions
- Registration Number
- NCT00871039
- Lead Sponsor
- Virginia Commonwealth University
- Brief Summary
The aim of this study is to evaluate the effects of the sedatives propofol and midazolam on stress response and immune function in critically ill patients with alcohol use disorders who are undergoing mechanical ventilation.
- Detailed Description
No detailed description
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Diagnosis of alcohol use disorders
- Need for invasive mechanical ventilation
- Need for continuous intravenous infusion of sedative(s)
Exclusion Criteria
- Age < 18 years
- Pregnant women
- Prisoners
- Receiving propofol prior to randomization
- Patient experiencing active alcohol withdrawal
- Immunosuppression
- Shock
- Attending physician does not feel patient is candidate to receive either propofol or midazolam
- Patient has contraindication(s) to receiving either propofol or midazolam
- Inability to enroll patient within 96 hours after initiation of mechanical ventilation
- Transfer from another intensive care unit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol Propofol Patients to be sedated for up to 72 hours with study drug propofol Midazolam Midazolam Patients to be sedated for up to 72 hours with study drug midazolam
- Primary Outcome Measures
Name Time Method Stress response and immune function. 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States