Collaborative Pediatric Critical Care Research Network - Clinical Site

儿科重症监护协作研究网络 - 临床网站

• 批准号: 10670235
• 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
• 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/10670235
• 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 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; Ethnic Origin; Faculty; Family; Functional disorder; Funding; Genetic; Goals; Good Clinical Practice; Granulocyte-Macrophage Colony-Stimulating Factor; Health; Hospitals; Immunophenotyping; Individual; Infant; Information Systems; Institution; Institutional Review Boards; Intensive Care; Interleukin 6 Receptor; Interleukin-1 Receptors; Lead; Leadership; Life; Medical; Medical center; Medicine; Mentored Clinical Scientist Development Program; 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; Race; 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; cardiac intensive care unit; clinical research site; disability; expectation; experience; 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 diversity; sample collection; socioeconomics; square foot; success; tertiary care; tocilizumab; trauma centers

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 儿科重症监护协作性研究网络(CPCCRN)是推动科学发展的关键 和儿科重症监护医学的实践。这一选址方案的总体目标是为 密歇根(CHM)，在医学博士凯瑟琳·梅尔特的领导下，继续作为新的和 扩展的CPCCRN。米尔特博士，过去15年在CPCCRN担任SITE-PI，是一名儿科重症医生，患有 丰富的临床和转化性研究经验。米尔特博士已经成功地指导了许多青少年 CHM和其他CPCCRN站点的调查人员，并为CPCCRN出版了大量科学出版物 CPCCRN。CHM是一家独立的、三级护理的学术儿童医院，位于密歇根州底特律， 服务于具有不同种族、民族和社会经济背景的儿童和家庭。中医药学的优势 一个临床站点包括新的(2017)儿科(PICU)和心脏(CICU)重症监护病房，总共有48个 每年提供2,000多张床位和门票。CHM提供全系列的儿科和外科专科。 是美国外科医生学院的1级儿科创伤中心和美国烧伤 协会儿科烧伤中心。除了CHM提供的资源外，Spectrum Health DeVos 密歇根州大急流城的儿童医院将在苏伦德的领导下作为辅助地点 拉贾塞卡兰，医学博士，公共卫生硕士。DeVos共有32张ICU床位，其中包括24张病床的PICU和8张病床的CICU；这些 这些单位每年接收约1500名儿童。CHM和DeVos将共同提供80个ICU 床位和年入院人数超过3,500人，使其能够全面参与大型随机对照试验(RCT)。 脓毒症致多器官功能障碍综合征(MODS)的个体化免疫调节研究 在这一应用中提出了一种大规模的个性化、有针对性的免疫功能管理RCT 脓毒症引起的多器官功能障碍综合征的儿童。这项试验解决了一种假设，即免疫抑制的儿童 受益于粒细胞巨噬细胞集落刺激因子(GM-CSF)，以及患有高度炎症的儿童 将受益于使用Anakinra(重组IL-1受体拮抗剂)或 Tocilizumab(IL-6受体阻断抗体)。福利将根据持续时间和严重程度进行评估 3个月和12个月时的器官功能障碍、与健康相关的生活质量和家庭功能。米尔特博士和 她的研究团队对这项试验所基于的CPCCRN研究非常熟悉，包括 免疫表型、GM-CSF剂量和给药的样本采集和处理方法， 以及与脓毒症相关的短期和长期结果的收集。Rajasekaran博士在 儿科MODS背后的致病机制使他非常适合进行这项试验。米尔特博士 和Rajasekaran博士参加CPCCRN得到了各自机构的全力支持，并 坚定致力于与CPCCRN其他网站和数据协调中心合作开展 拟议的研究以及将初级调查员纳入CPCCRN活动并对其进行指导。