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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：
10468845
负责人：
Ayse Akcan Arikan
金额：
$ 8.43万
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/10468845
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 Hispanic Hospitals Immune Immune System Diseases Individual Infant Inflammation Inflammatory Intensive Care International Intervention Trial Investigational Drugs Kidney Leadership Leukocytes Life Liver Liver Failure 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 Persons 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 mechanical circulatory support 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.

项目概要/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儿科重症监护研究网络（CPCCRN），指导CPCCRN的年轻研究人员成为独立的研究人员研究者，并实施多中心随机对照“个性化免疫调节，脓毒症诱导的多器官功能障碍”干预性试验。新组建的CPCCRN将扩大从7到24个临床研究中心（12个主要研究中心和12个辅助研究中心），这将是美国国立卫生研究院最大的儿科危重病研究中心。研究网络至今。我们在贝勒医学院（Baylor College of Medicine）-德克萨斯儿童医院（Texas Children's Hospital; 主站点）和圣安东尼奥儿童医院（CHofSA;辅助站点）非常热衷于作为新网站参与。TCH是美国最大的独立儿童医院系统，也是美国最大的儿童医院之一。最好的（2020-2021年《美国新闻与世界报道》排名第四的儿童医院）。我们有所有的儿科医生子专业并提供四级儿科中心预期的所有服务。我们有一个广泛的轨道在多中心临床试验中的成功合作记录，如儿科急性肺损伤和败血症研究者和儿科心脏网络。与我们的CHofSA合作伙伴一起，我们将提供获得163+24张病床，每年6000人次，使我们能够充分参与“个性化” 免疫调节在脓毒症诱导的多器官功能障碍（MODS）中的作用组件。我们的网站有几个非常有才华的年轻教师，谁拥有职业生涯发展赠款与创新的转化研究项目，并将有助于成功的 CPCCRN。例如，Desai博士（K12受体）开创了儿童缺血性心肌病领域，胆汁酸-心肌相互作用（胆心）。他的目标是通过以下方法改善小儿肝功能衰竭的预后：通过新的胆汁酸螯合剂和血液净化技术减少循环病理性胆汁酸。博士Lam（K 08受体）开发了一种新的蛋白质，通过抑制白细胞-血小板- 内皮细胞相互作用他的目标是改善儿童肝功能衰竭的预后，最近，COVID 19- 诱发炎症。阮博士，我们的合作研究者，是R 01资助研究脓毒症诱导的机制， MODS，并开发针对这种致命疾病的靶向新药。他的目标是获得新的研究药物状态为他的新A2蛋白从食品和药物管理局，并随后，进入A2 临床试验中的蛋白质，如CPCCRN。Arikan博士，我们的研究中心首席研究员，计划研究体外治疗的免疫调节和药代动力学的新疗法，以建立在她的以前在儿科MODS中的工作，特别强调急性肾损伤，获得性免疫功能障碍和MODS表型。