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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00871039
First received: March 26, 2009
Last updated: November 10, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Alcoholism
Mechanical Ventilation
 Drug: Propofol
Drug: Midazolam
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Clinical Trial Comparing Propofol and Midazolam in Mechanically Ventilated Critically Ill Patients With Alcohol Use Disorders: An Open Label Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Alcoholism
U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Stress response and immune function. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propofol
Patients to be sedated for up to 72 hours with study drug propofol
 Drug: Propofol
Patients to be sedated for up to 72 hours with study drug propofol
Experimental: Midazolam
Patients to be sedated for up to 72 hours with study drug midazolam
 Drug: Midazolam
Patients to be sedated for up to 72 hours with study drug midazolam

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871039

Locations
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Marjolein de Wit, M.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Marjolein de Wit, MD, MS, Assistant Professor of Medicine, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00871039     History of Changes
Other Study ID Numbers: VCU IRB HM12035
Study First Received: March 26, 2009
Last Updated: November 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Alcoholism
Mechanical ventilation

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Midazolam
Propofol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013