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：
10468847
负责人：
KATHLEEN L. MEERT
金额：
$ 7.8万
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/10468847
关键词：
Address Admission activity American American College of Surgeons Anti-Inflammatory Agents Area Award Beds Blocking Antibodies Burn Centers Cardiac Cardiovascular system Caring Child Childhood Clinical Clinical Oncology Supplement (K12)Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Collaborations Collection Contracts Critical Care Critical Illness Critically ill children Data Data Coordinating Center Development Dimensions Disease Doctor of Philosophy Dose Enrollment Faculty Family Functional disorder Funding Goals Good Clinical Practice Granulocyte-Macrophage Colony-Stimulating Factor Health Hospitals Immunophenotyping Individual Infant Information Systems Institution Institutional Review Boards Intensive Care Intensive Care Units Interleukin 6 Receptor Interleukin-1 Receptors Lead Leadership Life Medical Medical center Medicine Mentors Methods Michigan Mission Morbidity - disease rate Multiple Organ Failure National Institute of Child Health and Human Development Operative Surgical Procedures Organ Outcome Participant Pediatric Hospitals Performance Physician Executives Population Heterogeneity Procedures Productivity Program Development Protocols documentation Public Health Publications Randomized Controlled Trials Recombinants Research Research Personnel Research Training Resources Science Scientist Sepsis Services Severities Site Survivors Talents Translational Research Trauma Universities Utah Work anakinra antagonist base clinical research site disability expectation experience faculty research functional status health related quality of life high risk immune function immunoregulation immunosuppressed innovation meetings mid-career faculty mortality operation patient population pediatric trauma personalized medicine professor programs racial and ethnic racial diversity sample collection socioeconomics square foot success tertiary care tocilizumab trauma centers

项目摘要

PROJECT SUMMARY/ABSTRACT – Children's Hospital of Michigan The Collaborative Pediatric Critical Care Research Network (CPCCRN) is essential to advancing the science and practice of pediatric critical care medicine. The overall aim of this site proposal is for Children's Hospital of Michigan (CHM), under the leadership of Kathleen Meert, MD, to continue as a clinical site in the new and expanded CPCCRN. Dr. Meert, site-PI for the CPCCRN for the past 15 years, is a pediatric intensivist with a wealth of clinical and translational research experience. Dr. Meert has successfully mentored many junior investigators at CHM and other CPCCRN sites, and produced numerous scientific publications for the CPCCRN. CHM is a free-standing, tertiary care, academic children's hospital located in Detroit, Michigan, that serves children and families with diverse racial, ethnic and socioeconomic backgrounds. Strengths of CHM as a clinical site include the new (2017) Pediatric (PICU) and Cardiac (CICU) intensive care units with a total of 48 beds and over 2,000 admissions annually. CHM offers the full spectrum of pediatric and surgical subspecialty services, and is an American College of Surgeons Level 1 Pediatric Trauma Center and an American Burn Association Pediatric Burn Center. In addition to the resources available at CHM, Spectrum Health DeVos Children's Hospital in Grand Rapids, Michigan, will serve as an Ancillary Site under the leadership of Surender Rajasekaran, MD, MPH. DeVos has a total of 32 ICU beds that include a 24-bed PICU and 8-bed CICU; these units admit approximately 1,500 children annually. Together, CHM and DeVos will provide access to 80 ICU beds and over 3,500 annual admissions, enabling full participation in large randomized controlled trials (RCT). The “Personalized Immunomodulation in Sepsis-Induced Multiple Organ Dysfunction Syndrome (MODS)” trial proposed in this application is a large RCT of personalized, targeted management of immune function in children with sepsis-induced MODS. The trial addresses the hypothesis that immunosuppressed children will benefit from granulocyte macrophage-colony stimulating factor (GM-CSF), and children with hyperinflammation will benefit from targeted anti-inflammatory therapy with anakinra (recombinant IL-1 receptor antagonist) or tocilizumab (IL-6 receptor blocking antibody). Benefit will be evaluated in terms of duration and severity of organ dysfunction, and health-related quality of life and family functioning at 3 and 12 months. Dr. Meert and her research team are thoroughly familiar with the CPCCRN studies on which this trial is based including methods of sample collection and processing for immunophenotyping, dosing and administration of GM-CSF, and collection of short- and long-term sepsis-related outcomes. Dr. Rajasekaran has research expertise in the pathogenetic mechanisms underlying pediatric MODS making him well-suited to conduct this trial. Dr. Meert and Dr. Rajasekaran have the full support of their respective institutions to participate in the CPCCRN, and are strongly committed to collaboration with other CPCCRN sites and the Data Coordinating Center in conducting the proposed research, as well as the inclusion and mentoring of junior investigators in CPCCRN activities.

项目摘要/摘要 - 密歇根儿童医院儿科重症监护协作研究网络 (CPCCRN) 对于推进科学发展至关重要该站点提案的总体目标是儿童医院。密歇根州 (CHM) 在 Kathleen Meert 医学博士的领导下，继续作为新的和新的临床中心 Meert 博士是 CPCCRN 过去 15 年的现场 PI，是一名儿科重症医生。 Meert 博士拥有丰富的临床和转化研究经验，成功指导了许多初级人员。 CHM 和其他 CPCCRN 站点的研究人员，并为该研究撰写了大量科学出版物 CPCCRN 是一家独立的三级护理学术儿童医院，位于密歇根州底特律， CHM 的优势是为不同种族、民族和社会经济背景的儿童和家庭提供服务。临床中心包括新的（2017 年）儿科 (PICU) 和心脏 (CICU) 重症监护室，共有 48 个 CHM 提供全方位的儿科和外科专科服务，每年接待 2,000 多名床位。服务，是美国外科医生学会一级小儿创伤中心和美国烧伤中心协会儿科烧伤中心除了 CHM、Spectrum Health DeVos 提供的资源外。密歇根州大急流城的儿童医院将作为 Surender 领导下的附属医院 Rajasekaran，医学博士，公共卫生硕士，共有 32 个 ICU 床位，其中包括 24 个床位的 PICU 和 8 个床位的 CICU； CHM 和 DeVos 每年将收治约 1,500 名儿童，提供 80 个 ICU 的使用权。床位和每年超过 3,500 名入院人数，能够充分参与大型随机对照试验 (RCT)。 “脓毒症引起的多器官功能障碍综合征（MODS）的个性化免疫调节”试验本申请中提出的是一项针对免疫功能的个性化、有针对性的管理的大型随机对照试验。该试验提出了免疫抑制儿童会出现 MODS 的假设。受益于粒细胞巨噬细胞集落刺激因子 (GM-CSF) 和患有过度炎症的儿童将受益于阿那白滞素（重组 IL-1 受体拮抗剂）的靶向抗炎治疗或托珠单抗（IL-6 受体阻断抗体）的益处将根据持续时间和严重程度进行评估。 Meert 博士和 3 个月和 12 个月时的器官功能障碍以及与健康相关的生活质量和家庭功能。她的研究团队非常熟悉本试验所依据的 CPCCRN 研究，包括用于GM-CSF免疫表型、剂量和施用的样品收集和处理方法， Rajasekaran 博士拥有以下方面的研究专业知识： Meert 博士了解儿科 MODS 的致病机制，非常适合进行这项试验。 Rajasekaran 博士参加 CPCCRN 得到了各自机构的全力支持，并且致力于与其他 CPCCRN 站点和数据协调中心合作，大力开展拟议的研究，以及初级研究人员参与 CPCCRN 活动的纳入和指导。