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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This study has been withdrawn prior to enrollment.
(Due to logistical purposes)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00871039
First Posted: March 30, 2009
Last Update Posted: March 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
  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 Respiration, Artificial Drug: Propofol Drug: Midazolam Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Stress response and immune function. [ Time Frame: 6 months ]

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (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

Detailed Description:
No detailed description
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871039


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

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00871039     History of Changes
Other Study ID Numbers: VCU IRB HM12035
First Submitted: March 26, 2009
First Posted: March 30, 2009
Last Update Posted: March 1, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Virginia Commonwealth University:
Alcoholism
Mechanical ventilation

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