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

Randomized Clinical Trial Comparing Propofol and Midazolam in Mechanically Ventilated Critically Ill Patients With Alcohol Use Disorders: An Open Label Pilot Study

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00871039

Enrollment

Registered

2009-03-30

Start date

2009-03-31

Completion date

2009-03-31

Last updated

2016-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism, Respiration, Artificial

Keywords

Alcoholism, Mechanical ventilation

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

Interventions

DRUGPropofol

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

DRUGMidazolam

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Stress response and immune function.	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026