Actively Recruiting
Effect of Alcohol and Drugs of Abuse on Immune Function in Critically Ill Patients With Respiratory Failure
Led by University of Colorado, Denver · Updated on 2024-10-08
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how alcohol and drug use affects people hospitalized with lung infections or respiratory failure. Respiratory failure is a serious condition where the lungs cannot properly oxygenate the blood or remove carbon dioxide. The study focuses on adults admitted to the intensive care unit (ICU) with respiratory problems to understand the impact of alcohol, tobacco, and drug use on illness severity and outcomes. Participants include adult ICU patients with respiratory issues, some of whom require mechanical ventilation. Researchers will collect various biological samples like blood, breath condensate, urine, and hair during the first 10 days of hospital stay. A subset will also undergo bronchoalveolar lavage. The study follows patients during their hospital stay, expected to last about 17 days, with follow-ups at 3 and 6 months to assess alcohol use disorders and respiratory failure causes. During the study, participants will be monitored in the ICU, with samples collected to characterize alcohol and drug use. Researchers will observe the prevalence and causes of respiratory failure and how these relate to substance use. The study includes safety checks and tracks changes over time through hospital and follow-up visits, aiming to improve understanding of risks and complications in critically ill patients.
CONDITIONS
Brief Title
Effect of Alcohol and Drugs of Abuse on Immune Function in Critically Ill Patients With Respiratory Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult medical ICU patients admitted for a primary respiratory problem
- Expected to require ICU care for 48 hours or more
- Adults aged 18 to 90 years
- Patients with respiratory failure requiring mechanical ventilation
- Adult ICU patients previously admitted for respiratory problems requiring 48+ hours care
You will not qualify if you...
- Expected ICU care less than 48 hours
- Patients admitted to ICU not requiring ICU status (space issues)
- Patients unlikely to survive 48 hours
- Patients on comfort or hospice care
- Patients younger than 18 or older than 90 years
- Prisoners
- Pregnant patients
- Significant anemia or active bleeding (Hgb <8%, Hct <24%)
- For bronchoscopy: FiO2 >80%, PEEP >10 cm H2O
- Platelets less than 30,000 (chronic)
- Expected spontaneous breathing trial or extubation within 4 hours
- Endotracheal tube smaller than 7.5 F
- Patients dangerously agitated
- Outpatients with residency >40 miles from clinic, non-English/Spanish speakers, unable to perform procedures, chronic pulmonary or neurodegenerative diseases, prior ICU outside UCH
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 days before ICU admission
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days of hospitalization
Participants are observed and samples are collected to characterize alcohol and drug use during ICU stay.
Multiple sample collections over the first 10 days of ICU stay
Duration - Up to 6 months after ICU stay
Participants are followed up to assess respiratory failure and alcohol/drug use outcomes after hospital discharge.
Follow-up assessments at 3 and 6 months
Trial Site Locations
Total: 1 location
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
E
Ellen L Burnham, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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