Collaborative Pediatric Critical Care Research Network - Clinical Site
Collaborative Pediatric Critical Care Research Network - Clinical Site
批准号:
10468853
负责人:
MARK W HALL
金额:
$8.2万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
未结题
起止时间:
2021-08-13 至 2026-07-31
关键词:
Admission activityAfrican AmericanAncillary StudyAnti-Inflammatory AgentsAptitudeBedsBeliefBiologicalBiological MarkersCaringCatchment AreaCaucasiansCensusesChildChild CareChildhoodClinicalClinical ResearchClinical TrialsCollaborationsContractsCritical CareCritical IllnessCritically ill childrenDataData Coordinating CenterDevelopmentDiagnostic Reagent KitsDouble-Blind MethodEnrollmentEnsureFacultyFunctional disorderFundingGenerationsGoalsGood Clinical PracticeGranulocyte-Macrophage Colony-Stimulating FactorHispanicImmuneImmune responseImmunologic AdjuvantsImmunologic MonitoringImmunologic SurveillanceImmunologic TestsImmunologicsImmunophenotypingImmunosuppressionIn SituIndividualInflammationInfrastructureInpatientsInstitutionInterventionInvestigationKnowledgeLaboratoriesLaboratory ResearchLaboratory StudyLeadershipMedicineMentorsMentorshipMonitorMorbidity - disease rateMulticenter StudiesNursesOhioPatient RightsPatientsPediatric HospitalsPediatric Intensive Care UnitsPerformancePharmaceutical PreparationsPharmacy facilityPhenotypePlacebo ControlPlacebosPopulationProceduresProtocols documentationPublic HealthQuality of lifeRandomizedRandomized Clinical TrialsRecording of previous eventsRecoveryResearchResearch InfrastructureResearch InstituteResearch PersonnelResourcesRoleScientistSepsisSiteStandardizationSteelTalentsTimeTranslational ResearchUnited States National Institutes of Healthanakinraclinical centerclinical research sitedesignexpectationexperiencefunctional statushealth related quality of lifeimmune functionimmunoregulationimprovedinnovationmeetingsmembermortalitymultidisciplinarypatient orientedpatient populationpediatric sepsisprimary outcomeprospective testrestorationsafety and feasibilitysecondary outcomesystemic inflammatory responsetocilizumab
中文摘要
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,每年合计
3,500名患者的人口普查)和我们的辅助站点彩虹婴儿和儿童医院(24个儿科ICU
具有每年1,600名患者普查的床位),将成为协作的第四个周期的强大资产
儿科重症监护研究网络(CPCCRN)。这项建议的总体目标是推动这一领域的发展
通过合作开发和执行变革性的儿科重症护理医学
使危重儿童受益的研究。作为目前CPCCRN的站点之一,我们(Hall-Pi,Yates-Co-i,
Steel-RC)在学科招生和项目开发方面一直处于领先地位。霍尔医生的免疫力
国家儿童医院阿比盖尔·韦克斯纳研究所的监测实验室(ISL)已经
在该网络在本周期进行的两项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控的安全性和可行性
我们的双手,以及当前周期的物候败血症表型研究,直接将我们带到了
建议的研究,“脓毒症诱导的多器官功能障碍综合征的个性化免疫调节”。这项研究包括两个截然不同的
嵌入式、双盲、安慰剂对照、随机免疫调节临床试验,专为
每个受试者的前瞻性测试免疫表型。ISL将提供高度标准化的免疫
功能和炎症测试套件,该网络已经拥有丰富的经验。受试者
被发现有严重免疫抑制而没有严重炎症的人将被分配给“GM-CSF
用于逆转脓毒症诱导的MODS的免疫麻痹(GRACE)-2“他们将接受GM-CSF的研究
或者安慰剂。患有中度到重度全身炎症的受试者将被分配到
儿科脓毒症诱导的多器官功能障碍综合征(TRIPS)的炎症逆转“研究中,受试者将
适应性随机接受抗炎药Anakinra、tocilizumab或安慰剂。如此之高
创新的方法旨在确保合适的受试者接受匹配的合适的免疫护理
他们的免疫紊乱。我们的主要结果,28天内的累积PELOD-2评分将
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死亡率
与健康相关的生活质量。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医院
儿童医院(Shin-Pi,Slain-Co-I)肯定会在未来成为强有力的贡献者和合作者
CPCCRN的循环,并将通过产生新的、可概括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。
英文摘要
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.
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会议论文
Collaborative Pediatric Critical Care Research Network - Clinical Site
-
批准号:10393855
-
项目类别:
-
资助金额:$15.4万
-
财政年份:2021
-
负责人:MARK W HALL
-
依托单位:
Collaborative Pediatric Critical Care Research Network - Clinical Site
-
批准号:10670166
-
项目类别:
-
资助金额:$15.4万
-
财政年份:2021
-
负责人:MARK W HALL
-
依托单位:
Collaborative Pediatric Critical Care Research Network - Clinical Site
-
批准号:10470938
-
项目类别:
-
资助金额:$15.4万
-
财政年份:2021
-
负责人:MARK W HALL
-
依托单位:
Collaborative Pediatric Critical Care Research Network - Clinical Site
-
批准号:10670269
-
项目类别:
-
资助金额:$8.2万
-
财政年份:2021
-
负责人:MARK W HALL
-
依托单位:
Collaborative Pediatric Critical Care Research Network - Clinical Site
-
批准号:10248822
-
项目类别:
-
资助金额:$8.38万
-
财政年份:2021
-
负责人:MARK W HALL
-
依托单位:
PediAtric ReseArch of Drugs, Immunoparalysis and Genetics during MODS (PARADIGM)
-
批准号:10640818
-
项目类别:
-
资助金额:$60.6万
-
财政年份:2019
-
负责人:MARK W HALL
-
依托单位:
PediAtric ReseArch of Drugs, Immunoparalysis and Genetics during MODS (PARADIGM)
-
批准号:10151669
-
项目类别:
-
资助金额:$63.64万
-
财政年份:2019
-
负责人:MARK W HALL
-
依托单位:
PediAtric ReseArch of Drugs, Immunoparalysis and Genetics during MODS (PARADIGM)
-
批准号:10394894
-
项目类别:
-
资助金额:$61.96万
-
财政年份:2019
-
负责人:MARK W HALL
-
依托单位:
PediAtric ReseArch of Drugs, Immunoparalysis and Genetics during MODS (PARADIGM)
-
批准号:9923029
-
项目类别:
-
资助金额:$75.37万
-
财政年份:2019
-
负责人:MARK W HALL
-
依托单位:
Collaborative Pediatric Critical Care Research Network (UG1)
-
批准号:8991005
-
项目类别:
-
资助金额:$25.28万
-
财政年份:2014
-
负责人:MARK W HALL
-
依托单位:
Collaborative Pediatric Critical Care Research Network (UG1)
-
批准号:10055976
-
项目类别:
-
资助金额:$23.96万
-
财政年份:2014
-
负责人:MARK W HALL
-
依托单位:
GM-CSF for Immunomodulation Following Trauma (GIFT) Trial
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批准号:8473685
-
项目类别:
-
资助金额:$44.62万
-
财政年份:2011
-
负责人:MARK W HALL
-
依托单位:
GM-CSF for Immunomodulation Following Trauma (GIFT) Trial
-
批准号:8849457
-
项目类别:
-
资助金额:$47.72万
-
财政年份:2011
-
负责人:MARK W HALL
-
依托单位:
GM-CSF for Immunomodulation Following Trauma (GIFT) Trial
-
批准号:8669008
-
项目类别:
-
资助金额:$46.25万
-
财政年份:2011
-
负责人:MARK W HALL
-
依托单位:
GM-CSF for Immunomodulation Following Trauma (GIFT) Trial
-
批准号:8187717
-
项目类别:
-
资助金额:$50.1万
-
财政年份:2011
-
负责人:MARK W HALL
-
依托单位:
GM-CSF for Immunomodulation Following Trauma (GIFT) Trial
-
批准号:8329008
-
项目类别:
-
资助金额:$46.62万
-
财政年份:2011
-
负责人:MARK W HALL
-
依托单位:
Monocyte Pyrin Expression in Human Sepsis
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批准号:7134137
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项目类别:
-
资助金额:$13.23万
-
财政年份:2006
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负责人:MARK W HALL
-
依托单位:
Monocyte Pyrin Expression in Human Sepsis
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批准号:7262493
-
项目类别:
-
资助金额:$13.23万
-
财政年份:2006
-
负责人:MARK W HALL
-
依托单位:
Monocyte Pyrin Expression in Human Sepsis
-
批准号:7436321
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项目类别:
-
资助金额:$13.23万
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财政年份:2006
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负责人:MARK W HALL
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依托单位:
海外基金