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：
10248822
负责人：
MARK W HALL
金额：
$ 8.38万
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/10248822
关键词：
Admission activity African American Ancillary Study Anti-Inflammatory Agents Aptitude Beds Belief Biological Biological Markers Caring Catchment Area Caucasians Censuses Child Child Care Childhood Clinical Clinical Research Clinical Trials Collaborations Contracts Critical Care Critical Illness Critically ill children Data Data Coordinating Center Development Diagnostic Reagent Kits Double-Blind Method Enrollment Ensure Faculty Functional disorder Funding Generations Goals Good Clinical Practice Granulocyte-Macrophage Colony-Stimulating Factor Hispanics Immune Immune response Immunologic Adjuvants Immunologic Monitoring Immunologic Surveillance Immunologic Tests Immunologics Immunophenotyping Immunosuppression In Situ Individual Inflammation Infrastructure Inpatients Institution Intervention Investigation Knowledge Laboratories Laboratory Research Laboratory Study Leadership Medicine Mentors Mentorship Monitor Morbidity - disease rate Multicenter Studies Nurses Ohio Patient Rights Patients Pediatric Hospitals Pediatric Intensive Care Units Performance Pharmaceutical Preparations Pharmacy facility Phenotype Placebos Population Procedures Protocols documentation Public Health Quality of life Randomized Randomized Clinical Trials Recording of previous events Recovery Research Research Infrastructure Research Institute Research Personnel Resources Role Scientist Sepsis Site Standardization Steel Talents Time Translational Research United States National Institutes of Health anakinra clinical center clinical research site design expectation experience functional status health related quality of life immune function immunoregulation improved innovation meetings member mortality multidisciplinary patient oriented patient population primary outcome prospective test restoration safety and feasibility secondary outcome systemic inflammatory response tocilizumab

项目摘要

PROJECT SUMMARY/ABSTRACT – Nationwide Children’s Hospital Nationwide Children’s Hospital (54 pediatric ICU beds and 20 cardiothoracic ICU beds with a combined annual census of >3,500 patients) and our Ancillary Site, Rainbow Babies and Children’s Hospital (24 pediatric ICU beds with an annual census of >1,600 patients), will be strong assets to the 4th cycle of the Collaborative Pediatric Critical Care Research Network (CPCCRN). The overall aim of this proposal is to advance the field of pediatric critical care medicine through the collaborative development and execution of transformative studies that benefit critically ill children. As one of the current CPCCRN sites, we (Hall – PI, Yates – Co-I, Steel – RC) have consistently been leaders in subject enrollment and project development. Dr. Hall’s Immune Surveillance Laboratory (ISL) at the Abigail Wexner Research Institute at Nationwide Children’s Hospital has served a central role in the two interventional drug trials performed by the network this cycle. These trials using the immunostimulant drug GM-CSF for the reversal of critical illness-induced immune suppression, established the safety and feasibility of multi-center, real-time immune function monitoring and modulation in our hands and, along with the current cycle’s PHENOMS sepsis phenotyping study, led us directly to the proposed study, “Personalized Immunomodulation in Sepsis-induced MODS”. This study includes two distinct, embedded, double-blind, placebo-controlled, randomized clinical trials of immunomodulation that are tailored to each subject’s prospectively-tested immune phenotype. The ISL will provide highly standardized immune function and inflammation testing kits with which the network already has extensive experience. Subjects who are found to have severe immune suppression without severe inflammation will be allocated to the “GM-CSF for Reversal of Immunoparalysis in Sepsis-induced MODS (GRACE)-2” study where they will receive GM-CSF or placebo. Subjects with moderate to severe systemic inflammation will be allocated to the “Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)” study in which subjects will be adaptively randomized to receive the anti-inflammatory drugs anakinra, tocilizumab, or placebo. This highly innovative approach is designed to ensure that the right subject receives the right immune care that matches their immunologic derangement. Our primary outcome, the cumulative PELOD-2 score over 28 days, will assess both ICU morbidity and mortality, and our secondary outcomes will assess long term morbidity and health-related quality of life. This project is an ideal platform for ancillary studies and will represent a transformative approach to sepsis care in children. Nationwide Children’s Hospital and Rainbow Babies and Children’s Hospital (Shein – PI, Slain – Co-I) are certain to be strong contributors and collaborators in the next cycle of CPCCRN and will help move our field forward through the generation of new, generalizable knowledge that will inform the treatment of critically ill children.

项目摘要/摘要 - 全国儿童医院全国儿童医院（54张小儿ICU床和20张心胸ICU床，一年一度 > 3500名患者的人口普查）和我们的辅助部位，彩虹婴儿和儿童医院（24个小儿ICU）每年普查> 1600名患者的床）将是该协作的第四个周期的强大资产小儿重症监护研究网络（CPCCRN）。该提议的总体目的是推进该领域通过协作发展和执行变革性的小儿重症监护医学受益于重病孩子的研究。作为当前CPCCRN站点之一，我们（Hall - Pi，Yates - Co-I，钢铁 - RC）一直是受试者入学和项目开发的领导者。霍尔博士的免疫力全国儿童医院阿比盖尔·韦克斯纳研究所的监视实验室（ISL）在本周期由网络执行的两个介入药物试验中发挥了核心作用。这些试验使用免疫刺激药物GM-CSF逆转严重疾病诱导的免疫抑制，确定了多中心，实时免疫功能监测和调制的安全性和可行性我们的手，以及当前周期的现象败血症表型研究，直接导致我们进入拟议的研究，“败血症引起的mod中的个性化免疫调节”。这项研究包括两个不同的嵌入，双盲，安慰剂对照的，随机的免疫调节临床试验，这些试验是根据每个受试者的前瞻性免疫型。 ISL将提供高度标准化的免疫型网络已经拥有丰富经验的功能和注射测试套件。受试者谁发现没有严重感染的严重免疫抑制作用将分配给“ GM-CSF）为了逆转败血症诱导的mods（Grace）-2的研究，他们将接受GM-CSF 或安慰剂。中度至重度全身注射的受试者将分配给“针对性的” 小儿脓毒症诱导的mod（旅行）的炎症逆转”研究将是受试者自适应随机接收抗炎药Anakinra，Tocilizumab或安慰剂。这很高创新方法旨在确保正确的主题获得与之匹配的正确免疫护理他们的免疫学进化。我们的主要结果，累积的pelod-2在28天内得分，将评估ICU发病率和死亡率，我们的次要结果将评估长期发病率和与健康有关的生活质量。该项目是辅助研究的理想平台，将代表儿童败血症护理的变革性方法。全国儿童医院和彩虹婴儿，儿童医院（Shein - Pi，被杀 - Co-I）肯定是下一个贡献者和合作者 CPCCRN的循环，将有助于通过新的，可概括的知识来推动我们的领域前进这将为危重儿童的治疗提供信息。