The Human Subjects Core will conduct a prioritized translational research plan generated from UTHMS-Trauma Research Center activities. Studies will be performed in a well characterized, high risk cohort of severely injured patients managed in a standard fashion in the Shock Trauma Intensive Care Unit (STICU) at the Memorial Hermann Hospital (MHH). With increasing refinement of clinical research infrastructure, this study population offers a unique opportunity to study how inflammation and gut dysfunction contribute to adverse outcome related to post-injury multiple organ failure (MOF). Infrastructure for clinical research, including standardized protocols for shock resuscitation and enteral nutritional support, was established. This infrastructure,with continued refinement, will be used in the conduct of the clinical research proposed for this Core. Our long-term goal is to standardize key aspects of care in this high risk cohort (to minimize variability and insure best practice) and to document clinical outcomes of research interest. We are developing a clinical research platform to test for presence of a therapeutic effect (i.e. a signal) discriminated from background clinical noise. We propose clinical studies that are feasible and directly translate laboratory observations to the bedside: Ketamine Trial; and Bile Reflux Gastritis and alpha-Melanocyte Stimulating Hormone (alpha-MSH) Epidemiology studies. This research provides clinical translation. Junior faculty will be directly involved in epidemiology studies as MS Degree thesis projects with PIs as mentors. In recent years, 60-80 critically injured patients meeting criteria for shock resuscitation have been admitted to the ICU annually. We estimate that 30-40 of these patients/next of kin per year will consent to proposed clinical research. Human Subjects Research is carefully planned, reviewed and conducted. An Internal Advisory Board is proposed to focus planning, data review and patient safety for the TRC. We will also test innovative monitor technologies to improve ability to perceive basic GI functions, and to predict complications early.
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