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: 10670146
• 负责人: KATHLEEN L. MEERT
• 金额: $ 14.39万
• 依托单位: CENTRAL MICHIGAN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-18 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10670146
• 关键词: Collaborative; Pediatric; Critical; Care; Research

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 和儿科重症监护医学实践。该场地提案的总体目标是为儿童医院 密歇根州 (CHM) 在医学博士凯瑟琳·米尔特 (Kathleen Meert) 的领导下，继续作为新的和新的临床中心 扩大了 CPCCRN。 Meert 博士在过去 15 年中担任 CPCCRN 的现场 PI，是一名儿科重症监护医师，拥有 丰富的临床和转化研究经验。 Meert 博士已成功指导了许多初级 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。 CHM 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， 为具有不同种族、民族和社会经济背景的儿童和家庭提供服务。 CHM 的优势为 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 每年接待床位超过2000人次。 CHM 提供全方位的儿科和外科亚专业 服务，是美国外科医生学会 1 级小儿创伤中心和美国烧伤中心 协会小儿烧伤中心。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作为 Surender 领导下的附属医院 Rajasekaran，医学博士，公共卫生硕士。 DeVos共有32张ICU床位，其中包括24张床位的PICU和8张床位的CICU；这些 单位每年招收大约 1,500 名儿童。 CHM 和 DeVos 将共同提供 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。 患有败血症诱发的 MODS 的儿童。该试验提出了这样的假设：免疫抑制的儿童将 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）。效益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。梅尔特博士和 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， 以及收集短期和长期脓毒症相关结果。 Rajasekaran 博士拥有以下领域的研究专长： 儿科 MODS 的发病机制使他非常适合进行这项试验。梅尔特博士 Rajasekaran 博士参加 CPCCRN 得到了各自机构的全力支持，并且 坚定致力于与其他 CPCCRN 站点和数据协调中心合作开展 拟议的研究，以及初级研究人员参与 CPCCRN 活动的纳入和指导。