Effect of Alcohol and Drugs of Abuse on Immune Function in Critically Ill Patients With Respiratory Failure

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT02299921
Status
Recruiting
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Conditions

  • Alcohol Abuse
  • Drugs of Abuse
  • Infection
  • Lung Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Characterize alcohol and drug use — OTHER
    Characterize alcohol and drug use in patients newly admitted to the medical ICU service, who are expected to stay in the ICU for greater than 48 hours. The investigators will collect blood, exhaled breath condensate, urine and hair samples over the first 10 days of hospitalization. A select subset of subjects will have bronchoalveolar lavage (BAL) obtained.

Study Details

This study plans to learn more about people who are sick in the hospital with a lung infection, or respiratory failure. Respiratory failure, or severe lung failure, is a life-threatening disease. When it happens, the lungs have trouble carrying out their normal function of getting oxygen into the blood, and removing carbon dioxide from the body. Investigators are conducting this study to see what drinking too much alcohol, using tobacco products, or using drugs (both legal and illegal) may do to lung infections and respiratory failure. Subjects are asked to be in this research study because they are thought to have a lung infection and may also have respiratory failure. Alcohol, tobacco, and drug use have been linked to lung infections, respiratory failure, and even death, but the reasons for this aren't known. People who use unhealthy amounts of alcohol, tobacco, and or drugs may be more at risk for lung infections, and for severe complications due to lung infection. Subject participation is important whether or not you use alcohol and or drugs.

Key Dates

Start date
Nov 30, 2014
Status verified
Oct 2024
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Adult ICU patients with respiratory problem
    Adult medical ICU patients admitted to the University of Colorado Hospital for a primary respiratory problem, and who are expected to require ICU care ≥48 hrs.
  • Arm: Intubated Adult ICU patients with respiratory failure
    A subset of subjects, adult medical ICU patients with respiratory failure (due to underlying lung pathology) and who require endotracheal intubation and mechanical ventilation.

Primary Outcome Measure

Prevalence of alcohol use disorders (AUDs) [ Time Frame: prevalence, absolute value and change over 7 days, 3 Month follow up, 6 Month follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Carrie Higgins, BSN
[email protected]
720-848-4210
Jeff McKeehan, BSN
[email protected]
303-724-6080

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By research site
University of Colorado Hospital· Aurora, CO

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