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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：
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 的年轻研究人员变得独立研究人员，并实施多中心随机对照“个性化免疫调节” 脓毒症引起的多器官功能障碍”介入试验。新组织的CPCCRN将扩大 7 至 24 个临床中心（12 个主要中心和 12 个辅助中心），这将是最大的 NIH 儿科重症中心迄今为止的护理研究网络。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）非常热衷于作为新站点参与。 TCH 是美国最大的独立儿童医院系统，也是其中之一最好的（《2020-2021 年美国新闻与世界报道》儿童医院排名第 4）。我们有每一个儿科亚专科并提供四级儿科中心所需的所有服务。我们有广泛的轨道在小儿急性肺损伤等多中心临床试验中成功合作的记录败血症研究人员和儿科心脏网络。与我们的 CHofSA 合作伙伴合作，我们将提供拥有163+24张床位，年接待量6000人次，充分参与“个性化医疗” 脓毒症引起的多器官功能障碍（MODS）中的免疫调节”试验在总体中描述此应用程序的组件。我们的网站拥有几位才华横溢的年轻教师，他们拥有职业生涯创新转化研究项目的发展补助金，并将有助于 CPCCRN。例如，Desai 博士（K12 接受者）是小儿肝硬化心肌病领域的先驱，胆汁酸-心肌相互作用（胆心病）。他的目标是通过以下方式改善小儿肝衰竭的结果通过新型胆汁酸螯合剂和血液净化技术减少循环病理性胆汁酸。 Lam 博士（K08 获奖者）开发出新型蛋白质，通过抑制白细胞-血小板-来减轻炎症内皮相互作用。他的目标是改善小儿肝衰竭以及最近的新冠肺炎的治疗结果诱发炎症。我们的联合研究员 Nguyen 博士获得 R01 资助，研究脓毒症诱发的机制 MODS 并开发针对这种致命疾病的靶向新药。他的目标是获得研究性新成果他的新型 A2 蛋白获得美国食品和药物管理局的药物状态，随后进入 A2 CPCCRN等临床试验中的蛋白质。我们网站的首席研究员 Arikan 博士计划研究其影响体外疗法在免疫调节和药代动力学方面的新疗法的建立在她的基础上先前在儿科 MODS 方面的工作，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。