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

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00871039
• Other study ID #: VCU IRB HM12035
• Status: Withdrawn
• Phase: Phase 4
• First received: March 26, 2009
• Last updated: February 29, 2016
• Start date: March 2009
• Est. completion date: March 2009

Study information

• Verified date: February 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

No detailed description

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Alcoholism
• Respiration, Artificial

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress response and immune function.		6 months	No