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：
10468853
负责人：
MARK W HALL
金额：
$ 8.2万
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/10468853
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 Hispanic 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 Placebo Control 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 pediatric sepsis 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 张儿科 ICU 床位和 20 张心胸 ICU 床位，每年总计对超过 3,500 名患者进行的人口普查）以及我们的辅助站点彩虹婴儿儿童医院（24 个儿科 ICU 年度普查患者数量超过 1,600 名的床位）将成为第四轮合作的强大资产儿科重症监护研究网络 (CPCCRN) 该提案的总体目标是推动该领域的发展。通过协作开发和执行变革性的方法来发展儿科重症监护医学作为当前 CPCCRN 站点之一，我们（Hall – PI、Yates – Co-I、 Steel – RC）在霍尔博士的免疫领域一直处于领先地位。全国儿童医院阿比盖尔韦克斯纳研究所的监测实验室 (ISL) 在本周期网络进行的两项介入药物试验中发挥了核心作用。使用免疫增强药物 GM-CSF 来逆转危重疾病引起的免疫抑制，建立了多中心、实时免疫功能监测和调节的安全性和可行性我们的双手，以及当前周期的 PHENOMS 脓毒症表型研究，直接引导我们拟议的研究“脓毒症诱导的 MODS 的个性化免疫调节”这项研究包括两项不同的、嵌入式、双盲、安慰剂对照、随机的免疫调节临床试验，专门针对 ISL 将提供高度标准化的免疫表型。功能和炎症测试套件，该网络已经拥有丰富的经验。被发现有严重免疫抑制但没有严重炎症的将被分配到“GM-CSF 逆转脓毒症诱导的 MODS 中的免疫麻痹 (GRACE)-2”研究，他们将接受 GM-CSF 患有中度至重度全身炎症的受试者将被分配到“目标组”。儿科脓毒症诱发的 MODS 中炎症的逆转（TRIPS）”研究中，受试者将适应性随机接受抗炎药物阿那白滞素、托珠单抗或安慰剂。创新方法旨在确保正确的受试者获得相匹配的正确免疫护理我们的主要结果是 28 天内的累积 PELOD-2 评分。评估 ICU 发病率和死亡率，我们的次要结局将评估长期发病率和该项目是辅助研究的理想平台，并将代表全国儿童医院和彩虹婴儿的变革性儿童败血症护理方法。儿童医院（Shein – PI、Slain – Co-I）肯定会成为未来的强有力的贡献者和合作者 CPCCRN 的周期，将通过生成新的、通用的知识来帮助推动我们的领域向前发展这将为危重儿童的治疗提供信息。