Impact of Alcohol and Drugs on Immune Function in Critically Ill Patients with Lung Issues
Effect of Alcohol and Drugs of Abuse on Immune Function in Critically Ill Patients With Respiratory Failure
University of Colorado, Denver · NCT02299921
This study looks at how alcohol and drug use affects the immune system and recovery in critically ill patients with lung problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT02299921 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the effects of alcohol and drug use on immune function in critically ill patients suffering from respiratory failure and lung infections. By analyzing the health outcomes of patients admitted to the ICU with these conditions, the study seeks to understand how substance use may influence the severity of lung infections and overall recovery. Participants will be monitored for their alcohol, tobacco, and drug use to identify potential correlations with their respiratory health. The findings could provide insights into the risks associated with substance use in critically ill patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adult ICU patients with respiratory failure who are expected to require intensive care for at least 48 hours.
Not a fit: Patients who are expected to require ICU care for less than 48 hours or those on comfort care measures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for critically ill patients with respiratory failure, particularly those with substance use issues.
How similar studies have performed: While the specific focus on the impact of alcohol and drugs on immune function in this context may be novel, related studies have indicated that substance use can adversely affect respiratory health outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aurora, Colorado
- University of Colorado Hospital — Aurora, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Ellen L Burnham, MD — University of Colorado, Denver
- Study coordinator: Ellen L Burnham, MD
- Email: ellen.burnham@ucdenver.edu
- Phone: 303-724-6078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infection, Alcohol Abuse, Drugs of Abuse, Lung Injury