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: 10248825
• 负责人: MICHAEL W QUASNEY
• 金额: $ 8.47万
• 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/10248825
• 关键词: Address; Admission activity; Adult Respiratory Distress Syndrome; Beds; Cardiac; Caring; Child; Child Development; Child Health; Childhood; Childhood Injury; Clinical Oncology Supplement (K12); Clinical Trials; Clinical Trials Network; Collaborations; Contracts; Critical Care; Critical Illness; Critically ill children; Data; Data Coordinating Center; Development; Disease; Disease Management; Faculty; Funding; Goals; Good Clinical Practice; Granulocyte-Macrophage Colony-Stimulating Factor; Growth; Healthcare; Incidence; Individual; Infrastructure; Institutes; Institution; International; Leadership; Lung; Medical; Medicine; Mentored Clinical Scientist Development Program; Mentors; Michigan; Multiple Organ Failure; National Heart, Lung, and Blood Institute; National Institute of Child Health and Human Development; Outcome; Paper; Pediatric Acute Lung Injury; Pediatric Hospitals; Performance; Population; Positioning Attribute; Principal Investigator; Procedures; Process; Program Development; Protocols documentation; Publishing; Recording of previous events; Research; Research Personnel; Research Training; Resources; Sales; Scientist; Sepsis; Site; Talents; Training; Trauma; United States National Institutes of Health; Universities; Vision; Vulnerable Populations; Wisconsin; Work; clinical research site; efficacy evaluation; expectation; immunoregulation; implementation science; improved; insight; interdisciplinary approach; interest; medical schools; meetings; member; mindfulness; mortality; neurodevelopment; novel; participant enrollment; programs; severe injury; success; tertiary care

PROJECT SUMMARY/ABSTRACT – University of Michigan Pediatric Critical Care Medicine incorporates a multidisciplinary approach to address the medical needs of the most fragile population of critically ill and injured children. While current mortality rates at most academic, tertiary care children’s hospitals are below 5%, certain disease processes, notably sepsis and acute respiratory distress syndrome which are often accompanied with the presence of multiple organ dysfunction syndrome (MODS), remain associated with significantly higher mortality rates and utilize substantial health care resources. Despite this, the occurrences of these most challenging diseases do not occur sufficiently often at any one center to enable an effective, single-site study that will advance both our understanding and management of these diseases. Mindful of this reality, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) demonstrated great insight and vision in funding an infrastructure to create a multi-center research network, the Collaborative Pediatric Critical Care Research Network (CPCCRN). Our Pediatric Critical Care program at the University of Michigan, and the division Critical Care Medicine at the Children’s Hospital of Wisconsin and the Medical College of Wisconsin (MCW) who will participate as our ancillary site, have the infrastructure to allow us to actively participate in a number of multi-site studies. In addition to possessing this infrastructure, we also believe both sites have a team of investigators who can make important scientific and leadership contributions to the field. As a result, we are applying to participate within CPCCRN as a Clinical Site to assist in executing a large clinical trial investigating the efficacy of GM-CSF in critically ill children with sepsis entitled, Personalized Immunomodulation in Sepsis-induced MODS. We have the infrastructure and intellectual capacity to contribute in a meaningful way to the on-going growth and success of this research network that is committed to improving both the short- and long-term outcomes of critically ill and injured children. The goals of this proposal are for the Division of Pediatric Critical Care Medicine at the University of Michigan and our partner ancillary site, the Division of Pediatric Critical Care Medicine at the Medical College of Wisconsin to collaborate fully with the Executive Committee, the Data Coordinating Center and the other CPCCRN sites. In combination with our partner ancillary site, our site will provide access to over 100 PICU beds with over 4500 annual admissions, enabling us to participate fully in the “Personalized Immunomodulation in Sepsis-induced MODS” trial described in the overall component of this application. Our site proposal has three specific aims to achieve these goals: 1) to actively collaborate in implementation of the Collaborative Pediatric Critical Care Research Network clinical trial, 2) to provide opportunities for young investigators at the University of Michigan, as well as the Medical College of Wisconsin, to participate in CPCCRN meetings, committees, or trial implementation with the goal of developing these promising and talented individuals into fundable clinician scientists, 3) to implement the Personalized Immunomodulation in Sepsis-induced MODS trial.

项目摘要/摘要-密歇根大学 儿科重症监护医学结合了多学科的方法来满足 最脆弱的人口是危重和受伤的儿童。虽然目前的死亡率最高的是学术、高等教育 儿童护理医院低于5%，某些疾病过程，特别是脓毒症和急性呼吸窘迫 常伴有多器官功能障碍综合征(MODS)的综合征， 仍然与显著较高的死亡率有关，并利用大量的卫生保健资源。尽管 这种，这些最具挑战性的疾病的发生并不是在任何一个中心发生得足够频繁 实现有效的单点研究，这将促进我们对这些问题的理解和管理 疾病。考虑到这一现实，尤尼斯·肯尼迪·施莱弗国家儿童健康与人类研究所 发展(NICHD)在为基础设施提供资金以创建多中心方面展示了深厚的洞察力和远见 儿科重症监护协作性研究网络(CPCCRN)。我们的儿科危重病 密歇根大学的护理计划，以及密歇根大学儿童医院的重症护理医学部 威斯康星州和威斯康星州医学院(MCW)将作为我们的辅助站点参与， 基础设施，使我们能够积极参与多个地点的研究。除了拥有这个 基础设施，我们也相信这两个地点都有一支调查团队，他们可以做出重要的科学和 领导对该领域的贡献。因此，我们正在申请作为临床站点参与CPCCRN 协助开展一项大型临床试验，研究GM-CSF对重症脓毒症患儿的疗效 题为《脓毒症诱导的多器官功能障碍综合征的个性化免疫调节》。我们有基础设施和智力 能够以有意义的方式为该研究网络的持续增长和成功做出贡献，即 致力于改善危重和受伤儿童的短期和长期结果。的目标 这份提案是为密歇根大学儿科重症监护医学部和我们的合作伙伴 辅助网站，威斯康星医学院儿科重症监护医学部合作 与执行委员会、数据协调中心和中心的其他站点充分合作。结合在一起 通过我们的合作伙伴辅助网站，我们的网站将提供100多张PICU床位，每年超过4500张 入院，使我们能够充分参与“脓毒症诱导的多器官功能障碍综合征的个性化免疫调节” 在本应用程序的整体组件中描述的试验。我们的选址方案有三个具体目标要实现 这些目标：1)积极协作实施儿科重症监护协作性研究 网络临床试验，2)为密歇根大学的年轻研究人员提供机会，以及 威斯康星医学院，参加CPCCRN的会议、委员会或试验实施 将这些有前途和有才华的人培养成可资助的临床医生科学家的目标，3)实现 脓毒症诱导多器官功能障碍综合征的个体化免疫调节研究