RecruitingNCT02299921

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

Sponsor

University of Colorado, Denver

Enrollment

300 participants

Start Date

Nov 1, 2014

Study Type

OBSERVATIONAL

Conditions

Lung Injury Infection Alcohol Abuse Drugs of Abuse

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria2

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 Criteria29

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
Patients who required ICU care <48 hrs
Patients less than 18 or greater than 90 years of age
Patient is a prisoner
Patients who are pregnant
Residency > 40 miles from UCH clinics
non-English or non-Spanish speaking
Inability to perform study procedures (i.e. physical disability)
unable to perform pulmonary function testing
diagnosis of chronic pulmonary disease (e.g. COPD)
diagnosis of chronic neurodegenerative disease or severe dementia
history of anoxic or traumatic brain injury
prior ICU hospitalization at a non-UCH facility.

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Interventions

OTHERCharacterize 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.