HUMAN SUBJECTS CORE

人类主题核心

• 批准号: 7253220
• 负责人: BRUCE A MCKINLEY
• 金额: $ 19.87万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7253220
• 关键词: bile; clinical research; clinical trials; epidemiology; gastrointestinal disorder; gastrointestinal disorder chemotherapy; health care service planning; health services research tag; hormone regulation /control mechanism; human subject; human therapy evaluation; ketamine; melanocyte stimulating hormone; multiple organ failure; patient /disease registry; patient oriented research; trauma

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.

人类受试者核心将根据 UTHMS-创伤研究中心的活动制定优先转化研究计划。研究将在赫尔曼纪念医院 (MHH) 休克创伤重症监护病房 (STICU) 中以标准方式管理的一组特征明确的高风险重伤患者中进行。随着临床研究基础设施的日益完善，该研究人群提供了一个独特的机会来研究炎症和肠道功能障碍如何导致与损伤后多器官衰竭（MOF）相关的不良后果。建立了临床研究基础设施，包括休克复苏和肠内营养支持的标准化方案。该基础设施经过不断完善，将用于开展针对该核心的临床研究。我们的长期目标是标准化这个高风险人群的护理关键方面（以尽量减少变异性并确保最佳实践）并记录研究兴趣的临床结果。我们正在开发一个临床研究平台，以测试是否存在与背景临床噪音相区别的治疗效果（即信号）。我们提出可行的临床研究，并将实验室观察结果直接转化为临床：氯胺酮试验；胆汁反流性胃炎和α-黑色素细胞刺激激素（α-MSH）流行病学研究。这项研究提供了临床转化。初级教师将直接参与流行病学研究作为硕士学位论文项目，并以 PI 为导师。近年来，每年有60-80名符合休克复苏标准的重伤患者入住ICU。我们估计每年有 30-40 名患者/近亲同意拟议的临床研究。人类受试者研究是经过仔细规划、审查和进行的。建议成立一个内部咨询委员会来重点关注 TRC 的规划、数据审查和患者安全。我们还将测试创新的监测技术，以提高感知基本胃肠道功能并及早预测并发症的能力。