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



Status:Recruiting
Conditions:Infectious Disease, Hospital, Psychiatric, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - 90
Updated:3/30/2019
Start Date:November 2014
End Date:February 2023
Contact:Ellen L Burnham, MD
Email:ellen.burnham@ucdenver.edu
Phone:303-724-6078

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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.


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: Adult medical ICU patients with respiratory failure (due to underlying
lung pathology) and who require endotracheal intubation and mechanical ventilation

Exclusion criteria, Specific Aim 1 and 2:

- Patients who are expected to require ICU care <48 hrs

- Patients admitted to the MICU 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

- Patient without a designated proxy for consent

- 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.

- Patient has already undergone bronchoscopy within the past 48 hours

- Patient will undergo bronchoscopy for clinical purposes within the next 48 hours

- Patients who are mechanically ventilated for non-pulmonary pathology (e.g. airway
protection)

- Patients who are on either a fraction of inspired oxygen inspired oxygen fraction
(FiO2)>80% or 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
We found this trial at
1
site
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Phone: 720-848-4210
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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