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) logo

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Withdrawn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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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