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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：
10248823
负责人：
JOSEPH A CARCILLO
金额：
$ 8.43万
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/10248823
关键词：
Accounting Acute Renal Failure with Renal Papillary Necrosis Admission activity Anti-Inflammatory Agents Biological Markers Blinded Blood Brain Injuries Cessation of life Child Child Development Child Health Childhood Cities Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Collaborations Contracts Critical Care Critical Illness Critically ill children Data Data Coordinating Center Death Records Development Diagnostic Double-Blind Method Enhancers Enrollment Faculty Functional disorder Funding Futility Future Genetic Genetic study Goals Good Clinical Practice Heart Arrest Immune Immunologic Monitoring Individual Infant Infection Infection Control Inflammation Institutes Interleukin-6 Investigation Kansas Kidney Laboratories Liquid substance Manuscripts Masks Medical center Mentors Mentorship Molecular Biology Monoclonal Antibodies Morbidity - disease rate Multiple Organ Failure National Institute of Diabetes and Digestive and Kidney Diseases National Institute of General Medical Sciences National Institute of Neurological Disorders and Stroke Nurses Organ Outcome Parental Consent Patients Pediatric Hospitals Peer Review Performance Persons Phenotype Placebos Population Positioning Attribute Principal Investigator Procedures Protocols documentation Public Health Publishing Randomized Recombinant Granulocyte-Macrophage Colony-Stimulating Factors Recombinant Interleukin-1 Recombinants Research Research Personnel Research Training Resuscitation Role SECTM1 gene Scientist Sedation procedure Sepsis Site Study Section Syringes Talents Technology Testing Universities Work anakinra burden of illness clinical research site design expectation experience feasibility trial fighting fitness immunoregulation improved innovation meetings member mortality next generation participant enrollment pathogen randomized placebo controlled trial success treatment as usual

项目摘要

PROJECT ABSTRACT/SUMMARY – University of Pittsburgh Medical Center In this PL1 application, the UPMC Children’s Hospital of Pittsburgh and our ancillary site Mercy Children’s Hospital Kansas City are applying to be two of 24 patient enrolling centers in the new Eunice Kennedy Shriver National Institutes of Child Health and Development Collaborative Pediatric Critical Care Research Network. The first large randomized double blind placebo trial proposed by the steering committee to be undertaken is the “Personalized Immunomodulation in Sepsis-induced Multiple Organ Dysfunction Syndrome” trial in children. Sepsis occurs when infection overwhelms a person. If the patient’s organs shutdown then the patient develops Multiple Organ Dysfunction which can progress to Multiple Organ Failure and death. Sepsis kills one in 5 people worldwide with children accounting for the majority of these deaths. Death from sepsis is related in part to the patient not being able to fight infection as well as not being able to control inflammation. The molecular biology revolution offers us yet unproven hope that we can temper this ancient foe using technology that was not available in the past. After attaining parental consents we will draw blood from our children with sepsis and send it to Nationwide Children’s Hospital where their immune monitoring laboratory will determine whether our children are fighting infection and controlling inflammation well enough to survive, not fighting infection well enough, or not controlling inflammation well enough. If a child is not fighting infection well enough then we will be given masked syringes that will either be placebo (usual care), or recombinant Granulocyte-Macrophage Colony Stimulating Factor (immune enhancer) that our nurse will administer in a blinded randomization schema for seven days. If a child is not able to control inflammation well enough then we will be given masked syringes that will either be placebo (usual care), or recombinant Interleukin 1 receptor antagonist protein (anti-inflammatory), or Interleukin 6 monoclonal antibody (anti-inflammatory) that our nurse will administer in a blinded adaptive randomized fashion for seven days or one day, respectively. The Data Coordinating Center and the Data Safety Monitoring Board will determine whether treatment reduces organ, as well as when to stop enrollment for benefit, harm, or futility. Our two centers are well positioned to aid the success of the new network as 1) we provide 4800 patients per year for clinical studies making this planned trial and other future trials feasible; 2) we previously performed the pivotal studies on pediatric sepsis induced multiple organ failure that have been used to design the proposed trial thus assuring our expertise; and 3) we provide a group of young investigators who will become our field’s next generation of independent investigators with mentorship attained through participation in the network.

项目摘要/总结-匹兹堡大学医学中心在此PL 1应用程序中，匹兹堡UPMC儿童医院和我们的辅助站点Mercy Children's 堪萨斯城医院正在申请成为新的尤尼斯肯尼迪施莱佛24个患者登记中心中的两个美国国立儿童健康与发展研究所儿科重症监护协作研究网络。指导委员会建议进行的第一项大型随机双盲安慰剂试验是 “脓毒症诱导的多器官功能障碍综合征的个性化免疫调节”试验，孩子当感染使一个人死亡时，就会发生败血症。如果病人的器官停止工作发生多器官功能障碍，可发展为多器官衰竭和死亡。败血症导致一人死亡在全世界有5人死亡，其中儿童占这些死亡的大多数。败血症导致的死亡与部分原因是病人不能抵抗感染，也不能控制炎症。的分子生物学革命为我们提供了尚未证实的希望，我们可以利用技术来驯服这个古老的敌人，这在过去是没有的。在获得父母同意后，我们将从我们的孩子身上抽血，败血症，并将其送往全国儿童医院，他们的免疫监测实验室将确定我们的孩子是否能很好地抵抗感染和控制炎症，或者没有很好地控制炎症。如果一个孩子没有很好地抵抗感染，足够的话，我们将给予掩蔽注射器，将安慰剂（常规护理），或重组粒细胞-巨噬细胞集落刺激因子（免疫增强剂），我们的护士将管理在一个设盲随机化方案7天。如果孩子不能很好地控制炎症，我们将接受安慰剂（常规治疗）或重组白细胞介素1受体的掩蔽注射器拮抗蛋白（抗炎），或白细胞介素6单克隆抗体（抗炎），我们的护士将以盲法适应性随机方式分别给药7天或1天。数据协调中心和数据安全监测委员会将确定治疗是否减少器官，以及何时因受益、损害或无效而停止入组。我们的两个中心有很好的定位，以帮助新网络的成功，1）我们提供4800名患者，一年的临床研究，使这项计划的试验和其他未来的试验可行; 2）我们以前进行了关于儿科败血症引起多器官衰竭的关键研究已用于设计拟议的试验，从而确保我们的专业知识; 3）我们提供了一批年轻的研究人员，他们将成为我们领域的下一代独立调查员，通过参与网络获得指导。