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

NCT00871039 | Withdrawn Phase 4

• 1 other identifier: VCU IRB HM12035
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcoholism; Respiration, Artificial

Keywords

Alcoholism; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Stress response and immune function.

  6 months

Study Arms (2)

Propofol

EXPERIMENTAL

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

Drug: Propofol

Midazolam

EXPERIMENTAL

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

Drug: Midazolam

Interventions

Propofol DRUG

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

Propofol

Midazolam DRUG

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

Midazolam

Eligibility Criteria

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

You may qualify if:

• Diagnosis of alcohol use disorders
• Need for invasive mechanical ventilation
• Need for continuous intravenous infusion of sedative(s)

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (2)

Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)

Richmond, Virginia, 23298, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Alcoholism; Respiratory Aspiration

Interventions

Propofol; Midazolam

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Marjolein de Wit, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 1, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)