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

Tracking Information

First Received Date ^ICMJE

March 26, 2009

Last Updated Date

November 10, 2010

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00871039 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care

Condition ^ICMJE

Alcoholism
Mechanical Ventilation

Intervention ^ICMJE

Drug: Propofol
Patients to be sedated for up to 72 hours with study drug propofol
Drug: Midazolam
Patients to be sedated for up to 72 hours with study drug midazolam

Study Arm (s)

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

Intervention: Drug: Propofol
Experimental: Midazolam
Patients to be sedated for up to 72 hours with study drug midazolam

Intervention: Drug: Midazolam

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00871039

Other Study ID Numbers ^ICMJE

VCU IRB HM12035

Has Data Monitoring Committee

Responsible Party

Marjolein de Wit, MD, MS, Assistant Professor of Medicine, Virginia Commonwealth University

Study Sponsor ^ICMJE

Virginia Commonwealth University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marjolein de Wit, M.D.

Virginia Commonwealth University

Information Provided By

Virginia Commonwealth University

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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