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Recruiting NCT02299921

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

— Observational Infection Alcohol Abuse Drugs of Abuse Lung Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Characterize alcohol and drug use.
Who it may be relevant to
Registry conditions: Infection, Alcohol Abuse, Drugs of Abuse, Lung Injury. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Characterize 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.

Primary outcome measures

  • Prevalence of alcohol use disorders (AUDs) [Time frame: prevalence, absolute value and change over 7 days, 3 Month follow up, 6 Month follow up]
  • Incidence and etiology of respiratory failure, stratified by AUD/DUD/both/neither [Time frame: participants will be followed for the duration of hospital stay, an expected average of 17 days]
  • Incidence and etiology of respiratory failure, stratified by AUD/DUD/both/neither: Month 3 [Time frame: 3 Month follow up]
  • Incidence and etiology of respiratory failure, stratified by AUD/DUD/both/neither: Month 6 [Time frame: 6 Month follow up]

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)):

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Colorado Hospital — Aurora

Identifiers

NCT: NCT02299921 · 14-0630 · R24AA019661

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗