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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02299921
• Other study ID #: 14-0630
• Secondary ID: R24AA019661
• Status: Recruiting
• Start date: November 2014
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2023
• Source: University of Colorado, Denver
• Contact: Ellen L Burnham, MD
• Phone: 303-724-6078
• Email: ellen.burnham[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion criteria:

• Specific Aim 1: 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
• Specific Aim 2: (1) Adult medical ICU patients with respiratory failure (due to underlying lung pathology) and who require endotracheal intubation and mechanical ventilation. (2) Adult medical and other ICU patients with respiratory failure, not related to a lung condition, and who require endotracheal intubation and mechanical ventilation. (3) Adult ICU patients previously admitted to the University of Colorado Hospital for a primary respiratory problem, and who required care =48 hrs.

Exclusion criteria, Specific Aim 1 and 2:

• Patients who are expected to require ICU care <48 hrs
• Patients admitted to the ICU who are not ICU status (being housed for space issues)
• Patient is unlikely to survive 48 hours
• Patient is on comfort care (hospice measures)
• Patients less than 18 or greater than 90 years of age
• Patient is a prisoner
• ICU attending declines enrollment of patient
• Patients who are pregnant
• Patients who have significant anemia, defined as Hgb<8% or Hct<24%, or who have evidence of active bleeding. For bronchoscopy portion of Specific Aim 2.
• Patients who are on either a fraction of inspired oxygen inspired oxygen fraction (FiO2)>80% or positive end expiratory pressure (PEEP) >10 cm H20
• Patients with platelets less than 30,000(chronically)
• Patients who are expected to undergo a spontaneous breathing trial within the next 4 hours
• Patients with an order or plan to extubate in the next 4 hours
• Patients who have an endotracheal tube (ETT) <7.5 F
• Patients who are currently dangerously agitated
• Pregnant women

Exclusion criteria (outpatients ONLY for SA2 (3)):

1. Patients who required ICU care <48 hrs

2. Patients less than 18 or greater than 90 years of age

3. Patient is a prisoner

4. Patients who are pregnant

5. Residency > 40 miles from UCH clinics

6. non-English or non-Spanish speaking

7. Inability to perform study procedures (i.e. physical disability)

8. unable to perform pulmonary function testing

9. diagnosis of chronic pulmonary disease (e.g. COPD)

10. diagnosis of chronic neurodegenerative disease or severe dementia

11. history of anoxic or traumatic brain injury

12. prior ICU hospitalization at a non-UCH facility.

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Drugs of Abuse
• Infection
• Lung Injury
• Respiratory Insufficiency
• Substance-Related Disorders

Intervention

Other:
• Characterize alcohol and drug use
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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of alcohol use disorders (AUDs)	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.	prevalence, absolute value and change over 7 days, 3 Month follow up, 6 Month follow up
Primary	Incidence and etiology of respiratory failure, stratified by AUD/DUD/both/neither	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.	participants will be followed for the duration of hospital stay, an expected average of 17 days
Primary	Incidence and etiology of respiratory failure, stratified by AUD/DUD/both/neither: Month 3	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.	3 Month follow up
Primary	Incidence and etiology of respiratory failure, stratified by AUD/DUD/both/neither: Month 6	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.	6 Month follow up