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: 10248816
• 负责人: KATHLEEN L. MEERT
• 金额: $ 7.94万
• 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/10248816
• 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; 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

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.

项目概要/摘要-密歇根州儿童医院 协作儿科重症监护研究网络（CPCCRN）对于推进科学至关重要 和儿科重症监护医学的实践。本选址建议书的总体目标是： 密歇根州（CHM），在凯思琳米尔特，医学博士的领导下，继续作为一个新的和 扩大CPCCRN。Meert博士是过去15年CPCCRN的研究中心PI，是一名儿科重症监护医师， 丰富的临床和转化研究经验。Meert博士成功地指导了许多初级 研究人员在CHM和其他CPCCRN网站，并产生了许多科学出版物， CPCCRN。CHM是一个独立的，三级保健，学术儿童医院位于密歇根州底特律市， 为不同种族、族裔和社会经济背景的儿童和家庭提供服务。CHM的优势 一个临床站点包括新的（2017年）儿科（PICU）和心脏（CICU）重症监护病房，共48个 床位和每年超过2,000人次的入住CHM提供全方位的儿科和外科专科 服务，是美国外科学院1级儿科创伤中心和美国烧伤 协会小儿烧伤中心。除了在CHM可用的资源，频谱健康德沃斯 密歇根州大急流城的儿童医院将作为Surender领导下的辅助站点 Rajasekaran，MD，MPH. DeVos共有32张ICU床位，其中包括24张PICU和8张CICU;这些 这些单位每年接纳约1 500名儿童。CHM和DeVos将共同提供80个ICU 床位和超过3，500的年度入院，使充分参与大型随机对照试验（RCT）。 “脓毒症诱导的多器官功能障碍综合征（MODS）的个性化免疫调节”试验 在本申请中提出的是一项针对免疫功能的个性化、靶向管理的大型RCT， 脓毒症导致的MODS患儿该试验提出了免疫抑制儿童将 从粒细胞巨噬细胞集落刺激因子（GM-CSF）中获益， 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）。将根据持续时间和严重程度评价获益 器官功能障碍，以及3个月和12个月时的健康相关生活质量和家庭功能。Meert博士和 她的研究团队完全熟悉本试验所基于的CPCCRN研究，包括 用于免疫表型分析的样品收集和处理方法，GM-CSF的剂量和施用， 以及收集短期和长期脓毒症相关结果。Rajasekaran博士拥有研究专长， 儿科MODS的发病机制使他非常适合进行这项试验。米尔特医生 和Rajasekaran博士得到了各自机构的全力支持，参加了CPCCRN， 坚定地致力于与其他CPCCRN站点和数据协调中心合作， 拟议的研究，以及在CPCCRN活动中纳入和指导初级研究人员。