Pilot Study Evaluating Stress Response and Immune Function in Mechanically Ventilated Patients With Alcohol Use Disorders Treated With Propofol or Midazolam

Virginia Commonwealth University (VCU)

Status and phase: Withdrawn; Phase 4

Conditions: Alcoholism; Respiration, Artificial

Treatments: Drug: Midazolam; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT00871039

VCU IRB HM12035

Details and patient eligibility

About

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.

Full description

No detailed description

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Propofol

Experimental group

Description:

Patients to be sedated for up to 72 hours with study drug propofol

Treatment:

Drug: Propofol

Midazolam

Experimental group

Description:

Patients to be sedated for up to 72 hours with study drug midazolam

Treatment:

Drug: Midazolam