Collaborative Pediatric Critical Care Research Network - Clinical Site

项目摘要/摘要-贝勒医学院/德克萨斯儿童医院 当前提案的目标是重组和扩大协作式儿科危重护理 研究网络(CPCCRN)，指导CPCCRN的年轻研究人员走向独立 研究人员，并实施多中心随机对照的个性化免疫调节 脓毒症所致多器官功能障碍“干预性试验。新组建的CPCCRN将扩大 从7个到24个临床站点(12个主要站点和12个辅助站点)，这将是NIH最大的儿科危重病 到目前为止，护理研究网络。我们在贝勒医学院(BCM)-德克萨斯儿童医院(TCH； 主要站点)和圣安东尼奥儿童医院(CHofSA；辅助站点)对 作为新站点参与。TCH是美国最大的独立儿童医院系统，是 最佳(《美国新闻与世界报道2020-2021年》排名第四的儿童医院)。我们有所有的儿科 专科，并提供在第四儿科中心预期的所有服务。我们有一条宽阔的赛道 在多中心临床试验中成功协作的记录，如儿科急性肺损伤和 败血症调查人员和儿科心脏网络。与我们的CHofSA合作伙伴一起，我们将提供 提供163+24张床位和6000张年度入场券，使我们能够全面参与 脓毒症所致多器官功能障碍(MODS)的免疫调节“试验综述 此应用程序的。我们的网站有几名才华横溢的年轻教职员工，他们都有自己的职业生涯 为创新的翻译研究项目提供发展赠款，并将有助于 CPCCRN。例如，德赛医生(K12接受者)是儿科肝硬化性心肌病领域的先驱， 胆汁酸-心肌相互作用(胆心)。他的目标是通过以下途径改善儿童肝功能衰竭的预后 通过新型胆汁酸隔离剂和血液净化技术减少循环中的病理性胆汁酸。 林博士(K08获奖者)开发出新的蛋白质，通过抑制白细胞-血小板来减轻炎症- 内皮细胞的相互作用。他的目标是改善儿童肝功能衰竭的预后，最近，COVID19- 引起炎症。阮氏博士，我们的合作研究员，是R01资助的，用于研究脓毒症诱导的机制 并开发针对这种致命疾病的靶向新药。他的目标是获得调查新闻 他的新奇A2蛋白从食品和药物管理局获得的药物状态，随后进入A2 CPCCRN等临床试验中的蛋白质。阿里坎博士，我们的现场原则调查员，计划研究影响 以HER为基础的新疗法在免疫调节和药代动力学中的应用 儿童多器官功能障碍综合征的先前工作，特别强调急性肾损伤的相互作用，获得性 免疫功能障碍和MODS表型。

PROJECT SUMMARY/ABSTRACT – Baylor College of Medicine/Texas Children's Hospital The goals of the current proposal are to reorganize and expand the Collaborative Pediatric Critical Care Research Network (CPCCRN), to mentor young investigators in CPCCRN to become independent investigators, and to implement the multi-center randomized controlled “Personalized Immunomodulation in Sepsis-Induced Multiple Organ Dysfunction” interventional trial. The newly organized CPCCRN will expand from 7 to 24 clinical sites (12 Primary and 12 Ancillary sites), which will be the largest NIH Pediatric Critical Care Research Network to date. We at Baylor College of Medicine (BCM) - Texas Children's Hospital (TCH; Primary Site) and Children's Hospital of San Antonio (CHofSA; Ancillary Site) are very enthusiastic about participating as new sites. TCH is the largest freestanding children's hospital system in the U.S. and is one of the best (Rank #4 Children's Hospital by U.S. News & World Report 2020-2021). We have every pediatric subspecialty and offer every service expected in a quaternary pediatric center. We have an extensive track record of successful collaboration in multi-center clinical trials such as the Pediatric Acute Lung Injury and Sepsis Investigators and the Pediatric Heart Network. In combination with our CHofSA partner, we will provide access to 163+24 beds with 6000 annual admissions, enabling us to participate fully in the “Personalized Immunomodulation in Sepsis-induced Multiple Organ Dysfunction (MODS)” trial described in the Overall Component of this application. Our sites have several highly talented young faculty, who have career development grants with innovative translational research projects, and will contribute to the success of CPCCRN. For example, Dr. Desai (K12 recipient) pioneered the field of pediatric cirrhotic cardiomyopathy and bile acid-myocardial interaction (cholecardia). His aim is to improve outcomes of pediatric liver failure through decreasing circulating pathologic bile acids by novel bile acid sequestrants and blood purification techniques. Dr. Lam (K08 recipient) develops novel protein to attenuate inflammation through inhibiting leukocyte-platelet- endothelial interactions. His aim is to improve outcomes in pediatric liver failure and more recently, COVID19- induced inflammation. Dr. Nguyen, our Co-Investigator, is R01 funded to study mechanisms of sepsis-induced MODS and to develop targeted novel agent for this deadly disease. His aim is to obtain Investigational New Drug status for his novel A2 Protein from the Food and Drug Administration, and subsequently, to enter A2 Protein in clinical trials such as CPCCRN. Dr. Arikan, our site Principle Investigator, plans to study the impact of extracorporeal therapies in immunomodulation and pharmacokinetics of novel therapeutics to build on her previous work in pediatric MODS with a special emphasis on interaction of acute kidney injury, acquired immune dysfunction, and MODS phenotypes.