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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

Primary Purpose

Alcoholism, Respiration, Artificial

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Propofol
Midazolam
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alcoholism focused on measuring Alcoholism, Mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Propofol

Midazolam

Arm Description

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

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

Outcomes

Primary Outcome Measures

Stress response and immune function.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2009
Last Updated
February 29, 2016
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT00871039
Brief Title
Pilot Study Evaluating Stress Response and Immune Function in Mechanically Ventilated Patients With Alcohol Use Disorders Treated With Propofol or Midazolam
Official Title
Randomized Clinical Trial Comparing Propofol and Midazolam in Mechanically Ventilated Critically Ill Patients With Alcohol Use Disorders: An Open Label Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Due to logistical purposes
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Respiration, Artificial
Keywords
Alcoholism, Mechanical ventilation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Experimental
Arm Description
Patients to be sedated for up to 72 hours with study drug propofol
Arm Title
Midazolam
Arm Type
Experimental
Arm Description
Patients to be sedated for up to 72 hours with study drug midazolam
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Patients to be sedated for up to 72 hours with study drug propofol
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Patients to be sedated for up to 72 hours with study drug midazolam
Primary Outcome Measure Information:
Title
Stress response and immune function.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjolein de Wit, M.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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