RECRUITING

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

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Conditions

InfectionAlcohol AbuseDrugs of AbuseLung Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2014-11
Study Completion:2029-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02299921

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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.
  3. * Patients who are expected to require ICU care \<48 hrs
  4. * Patients admitted to the ICU who are not ICU status (being housed for space issues)
  5. * Patient is unlikely to survive 48 hours
  6. * Patient is on comfort care (hospice measures)
  7. * Patients less than 18 or greater than 90 years of age
  8. * Patient is a prisoner
  9. * ICU attending declines enrollment of patient
  10. * Patients who are pregnant
  11. * Patients who have significant anemia, defined as Hgb\<8% or Hct\<24%, or who have evidence of active bleeding.
  12. * Patients who are on either a fraction of inspired oxygen inspired oxygen fraction (FiO2)\>80% or positive end expiratory pressure (PEEP) \>10 cm H20
  13. * Patients with platelets less than 30,000(chronically)
  14. * Patients who are expected to undergo a spontaneous breathing trial within the next 4 hours
  15. * Patients with an order or plan to extubate in the next 4 hours
  16. * Patients who have an endotracheal tube (ETT) \<7.5 F
  17. * Patients who are currently dangerously agitated
  18. * Pregnant women
  19. 1. Patients who required ICU care \<48 hrs
  20. 2. Patients less than 18 or greater than 90 years of age
  21. 3. Patient is a prisoner
  22. 4. Patients who are pregnant
  23. 5. Residency \> 40 miles from UCH clinics
  24. 6. non-English or non-Spanish speaking
  25. 7. Inability to perform study procedures (i.e. physical disability)
  26. 8. unable to perform pulmonary function testing
  27. 9. diagnosis of chronic pulmonary disease (e.g. COPD)
  28. 10. diagnosis of chronic neurodegenerative disease or severe dementia
  29. 11. history of anoxic or traumatic brain injury
  30. 12. prior ICU hospitalization at a non-UCH facility.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Ellen L Burnham, MD
CONTACT
303-724-6078
ellen.burnham@ucdenver.edu

Principal Investigator

Ellen L Burnham, MD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

University of Colorado Hospital
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Ellen L Burnham, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-11
Study Completion Date2029-04-30

Study Record Updates

Study Start Date2014-11
Study Completion Date2029-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Infection
  • Alcohol Abuse
  • Drugs of Abuse
  • Lung Injury