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

Recruiting

• Conditions: Alcohol Abuse; Infection; Drugs of Abuse; Lung Injury
• Interventions: Other: Characterize alcohol and drug use

• Registration Number: NCT02299921
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Primary Completion: 2029-04-30
• Study Completion: 2029-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult ICU patients with respiratory problem	Characterize alcohol and drug use	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.
Intubated Adult ICU patients with respiratory failure	Characterize alcohol and drug use	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 Measures

Name	Time	Method
Incidence and etiology of respiratory failure, stratified by AUD/DUD/both/neither: Month 6	6 Month follow up	Among medical ICU (MICU) patients who develop respiratory failure: Incidence and etiology of respiratory failure, stratified by AUD/DUD/both/neither. Length of time on mechanical ventilation stratified by AUD/DUD/both/neither. Inflammatory profile of BAL stratified by AUD/DUD/both/neither: BAL cell count and differential, Pro-inflammatory BAL cytokines; CCL5, TNFa, interferon-gamma (IFNg), interleukin (IL-1b), interleukin (IL-6). Evidence of oxidative stress in BAL (GSH/glutathione disulfide (GSSG) ratio, pH). Alveolar macrophage activation, degree of apoptosis, and inflammatory cytokine production. Confirm in non-invasively collected samples. Development of Acute Respiratory Distress Syndrome (ARDS) stratified by AUD/DUD/both/neither; Berlin criteria, Lung injury score. 3 Month and 6 Month follow up were added to this outcome measure via a protocol amendment after study-start.
Incidence and etiology of respiratory failure, stratified by AUD/DUD/both/neither: Month 3	3 Month follow up	Among medical ICU (MICU) patients who develop respiratory failure: Incidence and etiology of respiratory failure, stratified by AUD/DUD/both/neither. Length of time on mechanical ventilation stratified by AUD/DUD/both/neither. Inflammatory profile of BAL stratified by AUD/DUD/both/neither: BAL cell count and differential, Pro-inflammatory BAL cytokines; CCL5, TNFa, interferon-gamma (IFNg), interleukin (IL-1b), interleukin (IL-6). Evidence of oxidative stress in BAL (GSH/glutathione disulfide (GSSG) ratio, pH). Alveolar macrophage activation, degree of apoptosis, and inflammatory cytokine production. Confirm in non-invasively collected samples. Development of Acute Respiratory Distress Syndrome (ARDS) stratified by AUD/DUD/both/neither; Berlin criteria, Lung injury score. 3 Month and 6 Month follow up were added to this outcome measure via a protocol amendment after study-start.
Prevalence of alcohol use disorders (AUDs)	prevalence, absolute value and change over 7 days, 3 Month follow up, 6 Month follow up	Among medical ICU (MICU) patients who remain in ICU greater than or equal to 48 hours: Prevalence of alcohol use disorders (AUDs), drug use disorders (DUDs), their combination (both), or no AUD/DUDs. Absolute value, and change over 7 days, in serum/urine/exhaled breath condensate/hair cortisol, corticotropin releasing hormone (CRH), adenovirus proteinase (AVP), and adrenocorticotropic hormone (ACTH), stratified by AUD/DUD/both/neither. 3 Month and 6 Month follow up were added to this outcome measure via a protocol amendment after study-start.
Incidence and etiology of respiratory failure, stratified by AUD/DUD/both/neither	participants will be followed for the duration of hospital stay, an expected average of 17 days	Among medical ICU (MICU) patients who develop respiratory failure: Incidence and etiology of respiratory failure, stratified by AUD/DUD/both/neither. Length of time on mechanical ventilation stratified by AUD/DUD/both/neither. Inflammatory profile of BAL stratified by AUD/DUD/both/neither: BAL cell count and differential, Pro-inflammatory BAL cytokines; CCL5, TNFa, interferon-gamma (IFNg), interleukin (IL-1b), interleukin (IL-6). Evidence of oxidative stress in BAL (GSH/glutathione disulfide (GSSG) ratio, pH). Alveolar macrophage activation, degree of apoptosis, and inflammatory cytokine production. Confirm in non-invasively collected samples. Development of Acute Respiratory Distress Syndrome (ARDS) stratified by AUD/DUD/both/neither; Berlin criteria, Lung injury score.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States