Collaborative Pediatric Critical Care Research Network - Clinical Site

儿科重症监护协作研究网络 - 临床网站

基本信息

批准号：
10248814
负责人：
Ayse Akcan Arikan
金额：
$ 8.65万
依托单位：
UNIVERSITY OF UTAH
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-13 至 2026-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10248814
关键词：
Acute Lung Injury Acute Renal Failure with Renal Papillary Necrosis Admission activity Area Arrhythmia Attenuated Beds Bile Acids Blood Blood Platelets COVID-19 Cardiac Cardiomyopathies Cardiovascular system Catchment Area Center for Translational Science Activities Child Childhood Cirrhosis Clinical Medicine Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Collaborations Communities Contracts Critical Care Critical Illness Data Data Coordinating Center Development Digestive System Disorders Disease Drug Kinetics Endothelium Enrollment Ethics Ethnic Origin Extramural Activities Faculty Family suidae Fostering Functional disorder Funding Goals Good Clinical Practice Grant Heart Hematology Hispanics Hospitals Immune Immune System Diseases Individual Infant Inflammation Inflammatory Intensive Care International Intervention Trial Investigational Drugs Kidney Leadership Leukocytes Life Liver Liver Failure Mechanics Medical center Medicine Mentors Mission Modeling Morbidity - disease rate Multi-Institutional Clinical Trial Multicenter Trials Multiple Organ Failure Myocardial National Institute of Child Health and Human Development Neonatal Nephrology Oncology Operative Surgical Procedures Organ Outcome Pathologic Patients Pediatric Acute Lung Injury Pediatric Hospitals Performance Phenotype Population Population Heterogeneity Principal Investigator Procedures Proteins Protocols documentation Publications Randomized Recording of previous events Reporting Research Research Institute Research Personnel Research Project Grants Research Training Resources Respiratory Diaphragm SECTM1 gene Scientist Sepsis Services Site System Talents Techniques Texas Therapeutic Agents Thrombosis Training Training Programs Translational Research United States United States Food and Drug Administration United States National Institutes of Health Work career development clinical research site cohort college ethnic diversity expectation immunoregulation improved outcome innovation machine learning algorithm medical specialties meetings mortality news novel novel therapeutics participant enrollment pediatric department porcine model pre-clinical programs prospective septic patients success

项目摘要

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.

项目摘要/摘要 - 贝勒医学院/德克萨斯儿童医院当前建议的目标是重组和扩展协作小儿重症监护研究网络（CPCCRN），向CPCCRN的心理年轻调查员建立独立调查人员，并实施多中心随机控制的“个性化免疫调节败血症引起的多器官功能障碍”介入介入试验。新组织的CPCCRN将扩展从7到24个临床部位（12个主要和12个辅助部位），这将是最大的NIH儿科关键护理研究网络迄今为止。我们在贝勒医学院（BCM） - 德克萨斯州儿童医院（TCH；主要地点）和圣安东尼奥儿童医院（Chofsa；辅助站点）非常热衷于作为新站点参与。 TCH是美国最大的独立儿童医院系统，是最好的（美国新闻与世界报告2020-2021的第四名儿童医院）。我们有每个小儿亚专业，并在第四纪小儿中心提供预期的每项服务。我们有一条广阔的轨道在多中心临床试验中成功合作的记录，例如小儿急性肺损伤和败血症研究人员和小儿心脏网络。结合我们的Chofsa合作伙伴，我们将提供访问163张床，每年6000张床，使我们能够完全参与“个性化败血症诱导的多器官功能障碍（MOD）的免疫调节”在总体上描述的试验此应用程序的组成部分。我们的网站有几个才华横溢的年轻教师，他们有职业通过创新的翻译研究项目赠款，并将为 CPCCRN。例如，Desai博士（K12接受者）开创了小儿肝硬化心肌病和胆汁酸心肌相互作用（胆跟心动过速）。他的目的是通过通过通过新型的胆汁酸螯合剂和血液纯化技术降低循环病理胆汁酸。 Lam博士（K08接受者）开发了新型蛋白质，通过抑制白细胞 - 静脉 - 内皮相互作用。他的目的是改善小儿肝衰竭的预后，最近，Covid19- 诱发炎症。我们的共同研究器Nguyen博士由R01资助用于研究败血症诱导的机制 mods并为这种致命疾病开发针对性的新手。他的目的是获得新的调查他的新型A2蛋白的药物状态来自食品药品监督管理局，随后进入A2 临床试验中的蛋白质，例如CPCCRN。我们的现场主要研究人员阿里坎博士计划研究影响新型疗法的免疫调节和药代动力学中的体外疗法以建立在她身上以前的小儿mod工作，特别着重于急性肾脏损伤的相互作用免疫功能障碍和MOD表型。