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Search / Trial NCT02299921

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

Launched by UNIVERSITY OF COLORADO, DENVER · Nov 20, 2014

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how alcohol and drug use affect the immune system in patients who are critically ill with lung infections or respiratory failure, which is a serious condition where the lungs can't provide enough oxygen to the body. Researchers want to understand if using substances like alcohol, tobacco, or drugs increases the risk of lung infections and complications in these patients. Participation is open to adults aged 18 to 90 who are in the ICU and expected to need care for at least 48 hours due to respiratory issues.

If you or a loved one qualifies for this study, you can expect to provide information about your health and substance use, which will help researchers learn more about these risks. Even if you do not use alcohol or drugs, your participation is valuable. This research may help improve care for future patients facing similar health challenges.

Gender

ALL

Eligibility 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.

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Aurora, Colorado, United States

Patients applied

0 patients applied

Trial Officials

Ellen L Burnham, MD

Principal Investigator

University of Colorado, Denver

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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