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Colorado Pulmonary-Alcohol Research Consortium (CoPARC)

 

Consortium Research Subjects and Patients


Subjects with AUDs will undergo single time point or longitudinal sampling at the University of Colorado and Emory University. Denver is home to a large population of racially and ethnically diverse AUD subjects, including Hispanics, while Atlanta has a sizable African-American population. Denver investigators have enrolled subjects with AUDs through regular screening at Denver Comprehensive Addictions Rehabilitation and Evaluation Services (CARES), while Emory investigators have enrolled subjects at the Atlanta Veteran’s Affairs (VA) Hospital. The majority of subjects with AUDs will undergo a single bronchoscopy, while 30% will have two sequential bronchoscopies performed. The performance of two bronchoscopies in AUD patients will support investigations seeking to establish the persistence of alcohol-related abnormalities. Longitudinal sampling will occur after 1 week of observed alcohol abstinence in an inpatient setting (Denver site), or after 2 or 3 weeks’ outpatient abstinence (Emory site).

Inclusion and exclusion criteria for AUD subjects:
  • Inclusion criteria: An Alcohol Use Disorders Identification Test (AUDIT) score of ≥ 8 for men, ≥ 5 for women; last alcohol-containing beverage consumed within the 7 days prior to enrollment; subjects who acknowledge cigarette smoking or cannabis smoking will also be considered.
  • Exclusion criteria: history of co-morbidity requiring daily medication (except HTN); concurrent illicit drug use; abnormal chest radiograph or spirometry; age < 18 or > 55.

Clinical protocol. Detailed screening exams will be performed including a full history (demographic, alcohol, tobacco use), physical exam, blood work, chest radiograph, simple spirometry, urine toxicology and cotinine testing, and pregnancy tests (in women). Cigarette and/or cannabis use, if present, will be quantified with validated methods. Abnormal findings (denoted in exclusion criteria) will result in a subject’s exclusion. Subjects will undergo research sampling, including bronchoscopy with BAL and bronchial brushings the morning following admission to ensure active alcohol withdrawal has been addressed if present. Along with subjects who smoke (majority of AUD subjects) active recruitment of AUD subjects who do not smoke either cigarettes or cannabis will also occur to support focused investigations of AUDs.

The University of Colorado investigators currently have IRB approval to enroll healthy control subjects who are smoking-, age- and sex- matched to complement AUD subject recruitment. Control subjects will be pair-matched to AUD subjects based on smoking (yes or no, cigarettes or cannabis), age, sex, and whenever possible, race. Non-AUD controls will undergo a single bronchoscopy.

Inclusion and exclusion criteria for controls.
  • Inclusion criteria: An AUDIT score of < 2 for men, < 1 for women. Subjects who acknowledge cigarette smoking or cannabis smoking will also be considered as needed for collaborators’ studies, and will complement habits in subjects with AUDs.
  • Exclusion criteria: Subjects will be ineligible to participate if they meet any of the criteria set forth for subjects with AUDs.

Clinical Protocol. A detailed history, physical, and screening exam will be performed as described for AUD subjects. Both cigarette and/or cannabis use will be verified by point of care urine testing, and quantified when present with validated methods. Abnormal findings will result in exclusion.

Patients will be recruited and enrolled from ICUs at the University of Colorado Hospital, including patients both at risk for, and with, the acute respiratory distress syndrome (ARDS). AUDs are expected to be present in 25-40% of enrolled patients, and approximately 45% of enrolled patients are expected to develop frank ARDS. A small percentage of patients are mechanically ventilated for non-pulmonary indications (e.g. airway protection in stroke). Enrollment of these patients who are mechanically ventilated for non-pulmonary indications will create a separate "control" group that will enable investigators to account for effects of mechanical ventilation on experimental variables. Detailed alcohol, smoking, and drug use history will be obtained on all enrolled patients. It is anticipated that 50% will have BAL samples available.

Inclusion and exclusion criteria for respiratory failure patients

  • Inclusion criteria: Patients ≤ 48 hours after endotracheal intubation on mechanical ventilation who are not undergoing attempts at spontaneous breathing.
  • Exclusion criteria: Age < 18; co-morbid malignancy; tracheostomy; use of immunosuppressive medications; autoimmune or chronic inflammatory diseases; patients admitted > 48 hours after mechanical ventilation.

Clinical protocol. The designated health care proxy will participate in the informed consent process, and re-consent of patients will occur once capacity is regained. Alternatively, consent may be waived depending on the sample(s) to be collected After consent, demographic information and research sampling will be completed as soon as feasible at designated time points while patient is in the ICU.

Investigators at Loyola University Medical Center and the University of Colorado will enroll burn-injured patients to explore the impact of AUDs on outcomes. Both sites obtain alcohol histories, and 12-25% of burn patients are expected to meet criteria for AUDs. From 1-2 patients will undergo bronchoscopy each month (at each site).

Inclusion and exclusion criteria for burn-injured patients are the same across the Loyola and University of Colorado sites.

  • Inclusion criteria: Patients ≥ 18 years of age, admitted < 24 hours after burn injury with total body surface area burn ≥ 15% or suspected inhalational injury; expected to require hospital care > 48 hours.
  • Exclusion criteria: Age < 18; co-morbid malignancy, use of immunosuppressive medications; known autoimmune or chronic inflammatory diseases; and patients who are admitted > 24 hours after injury.

Screening protocol. The designated health care proxy will participate in the informed consent process followed by re-consent of patient when capacity is regained. Demographic information, including AUDIT information and research sampling will be completed as soon as feasible while patient is in the ICU.​