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Major clinical portions of the protocol will be conducted at the University of Colorado Hospital (UCH), the Rocky Mountain Region’s only academic medical center and one of America’s Best Hospitals. Within this hospital, members of the Pulmonary Sciences and Critical Care Division have a long history of successful basic and clinical sciences research funding, and as such, the division is consistently ranked among the top in the country. Research subjects with AUDs and controls will be admitted and cared for at the UCH - Clinical and Translational Research Center (UCH-CTRC) that will provide the infrastructure and expertise to facilitate this research. The UCH-CTRC is one component of the Colorado Clinical and Translational Sciences Institute (CCTSI). The UCH-CTRC inpatient unit is located on the 12th floor of the hospital. It includes 4 ICU rooms and 9 step-down or medical/surgical patient rooms. In addition to providing inpatient and outpatient facilities and staff support, the adult unit supports an array of specialized resources for investigators, including: bionutrition core, metabolic kitchen, and core laboratory. The UCH-CTRC inpatient unit provides 24 hour staffing, and all registered nurses on the UCH-CTRC are required to have ACLS and BLS certifications. The UCH-CTRC has the experience and monitoring equipment to manage simple pharmacokinetic studies to complex ICU studies.
At the UCD site, subjects with AUDs will be recruited from Denver Comprehensive Addictions Rehabilitation and Evaluation Services (Denver CARES), a 100-bed, non-medical, clinically managed residential detoxification facility affiliated with Denver Health and Hospital System. Its mission is to provide safe detoxification for public inebriates and to provide assessment, education, and motivational counseling. It operates 24 hours, seven days a week, with a staff of registered nurses, licensed practical nurses, psychiatric technicians, addiction counselors and social workers. There are 24,000 admissions to this facility annually (Table 1). Control subjects may be recruited from the Denver VA Medical Center’s smoking cessation clinic. This clinic meets monthly, and is led by nurse practitioners in an outpatient setting. Approximately 20 patients per month attend the clinic and weekly classes.
Research subjects with burn injury will also be enrolled from the UCH Burn Intensive Care Unit (BICU), the only Burn Center in Colorado to be verified by the American Burn Association. The BICU is located on the 3rd floor of UCH, and includes 11 fully equipped inpatient ICU beds. Specialized resources provided for this unit include 24 hour staffing with either a 1:2 or 1:1 nurse: patient ratio; expertise in burn wound care; ACLS/BLS certification by nursing personnel. The average yearly census is 166 patients, with an average age of 44, who are 74% men. Approximately 17% have a history of AUDs, and 9% present acutely intoxicated.
Research subjects will also be recruited from sites associated with Emory University. Members of the Pulmonary, Allergy, and Critical Care Division at this site have significant experience in the conduct of human subjects’ research, with a lengthy funding history. Research subjects with AUDs and matched controls will be recruited from the Atlanta VA Medical Center’s Alcohol and Drug Detoxification Clinic, as well as its smoking cessation clinic. Both clinics meet monthly (in separate locations), and have approximately 30 patients that attend each clinic. The Atlanta VAMC has a fully staffed bronchoscopy suite where subjects can be scheduled as outpatients to perform research protocols. Nursing and other personnel are well-educated in the conduct of research protocols related to the subject matter of this proposal. The Atlanta VA Medical Center is a 350-bed acute medical-surgical VA hospital located in Decatur, GA, less than 1 mile from the EUMC campus where samples will be processed. Subjects with AUDs may also be recruited from the Grady Memorial Hospital’s Emergency Department, a large, urban, level I trauma facility operated by the City of Atlanta in conjunction with Emory University. There are approximately 250 patients seen in the Grady ED each day, of which ~20% have a history of AUDs. AUD subjects and healthy controls (other than the Atlanta VA population) will be admitted for research purposes to the ACSTI Clinical Interaction Network Site at Grady Memorial Hospital to undergo protocols related to this proposal. This research unit is located on the 12th floor of the hospital and is staffed with experienced nurses who will be educated regarding protocols in this population.
Healthy control subjects will be recruited from the general medicine and pulmonary clinics at Medical Center of Louisiana-New Orleans (MCLNO). There were 94,712 outpatient visits at MCLNO in 2008, which represents a 61% increase compared to the previous year. Currently, 81% of patients are African-American and 69% female in the medicine clinics (75% and 55%, respectively, in the pulmonary clinics). The clinics serve a population that is at or below 300% of the federal poverty level (97% of patients). All clinical testing will be performed in the LSUHSC/Tulane CTRC. This CTRC involves extensive interdisciplinary cooperation between the three local major medical institutions: Louisiana State University Health Sciences Center, Tulane University Health Sciences Center and the Medical Center of Louisiana whose facility is shared for teaching and service purposes with both Medical Schools. The Centers all form what is known locally as the New Orleans Medical Complex. The LSUHSC CTRC is located on the fourth floor of the LSU Interim Hospital. These rooms will serve as outpatient exam rooms when not utilized as inpatient rooms. The physical facility provides the appropriate space and capabilities necessary for the implementation of any approved protocol utilizing CTRC services. Respiratory tract sampling will be performed in the Bronchoscopy Suites at the Interim LSU Public Hospital, New Orleans. These suites contain the full armamentarium of equipment required for conducting the proposed studies. Tulane University Hospital and Clinic (TUHC) is located directly across the street from Tulane University Medical School. The CTRC is presently located on the second floor of TUHC in the Reilly Pavilion area of the facility and adjacent to the Laboratory Department. All ancillary services are within walking distance of the CTRC. The physical facility of the present CTRC outpatient clinic provides the appropriate space and capabilities for the implementation of all approved research activities. Moreover, LSU is home to its own NIAAA-funded Alcohol Research Center.
The Burn Unit at Loyola University Medical Center will be another location for the clinical component of the research. The Burn Unit has 21 beds with 10 ICU beds and an 11 bed step down unit. It is located in a building that is directly attached to the Burn Shock Trauma Institute (BSTI). Presently, the research group is providing educational and research experience for 8 graduate students, 6 post-doctoral fellows, 4 surgical residents through funding from 2 NIH training grants. Staff members in the burn unit are experienced in the conduct of human subjects’ research in patients with burn injury. Specimens will be collected in the Burn Unit and transported to the laboratory in the BSTI, located within the EMS building for processing and cellular analysis.
Our site has a strong interest in how alcohol intake impairs airway epithelial innate immunity. Our site will measure alcohol’s effect on the innate immune functions of ciliary beat frequency, toll-like receptor expression and signaling, as well as scavenger receptor function. These investigations will help us to understand how alcohol impairs pulmonary innate immunity and will allow us to develop better treatments for pulmonary disease related to alcohol use disorders.
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