Pediatric Heart Network Prairieland Consortium
儿科心脏网络 Prairieland 联盟
基本信息
- 批准号:8496609
- 负责人:
- 金额:$ 46.03万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2011
- 资助国家:美国
- 起止时间:2011-09-01 至 2016-06-30
- 项目状态:已结题
- 来源:
- 关键词:18 year oldAcetylcysteineAcuteAcute Renal Failure with Renal Papillary NecrosisAddressAdultAffectAgeAnimalsAntioxidantsArea Under CurveAttenuatedBasic ScienceBedside TestingsBiological MarkersCardiac Surgery proceduresCardiomyopathiesCardiopulmonary BypassCardiovascular systemChildChildhoodClinicalClinical MedicineClinical ResearchClinical TrialsCombined Modality TherapyComplicationConsentCreatinineCreatinine clearance measurementDevelopmentDiagnosisDiagnosticDouble-Blind MethodEarly InterventionEarly treatmentEchocardiographyEnrollmentFailureGelatinase AGenomicsHeartHospitalsHourIncidenceInjuryInterventionKidneyKnowledgeLength of StayMechanical ventilationMedicalMedical centerMissionMorbidity - disease rateMyocardialOperative Surgical ProceduresOutcomeOutputPathogenesisPatient RecruitmentsPatientsPediatric HospitalsPilot ProjectsPlacebo ControlPlacebosPlasmaPrincipal InvestigatorProteomicsPublic HealthRandomizedRelative (related person)Renal Replacement TherapyRenal functionResearchRiskSecondary toSerumServicesSeveritiesSodium BicarbonateStratificationSupportive careTechnologyTestingTherapeuticTherapeutic EffectTherapeutic InterventionTimeTranslatingTreatment FailureTroponinUrinebaseburden of illnessclinically significantexperienceimprovedmortalitynovelpatient populationpoint of carepreventprogramsprospectiveservice utilizationstandard caretrial comparingurinary
项目摘要
DESCRIPTION (provided by applicant):
This Clinical Center (Prairieland Consortium) is a collaborative effort among the Pediatric Cardiovascular Programs at Cincinnati Children's Hospital Medical Center, Cincinnati, OH and Riley Hospital for Children, Indianapolis, IN. Previous experience in the Pediatric Heart Network (PHN), an outstanding research team and the Consortium's combined patient population, characterized by >500 open heart surgeries and >20,000 echocardiograms annually, support an ability to contribute significantly to patient recruitment for PHN trials. The Clinical Trial we propose addresses an important gap in clinical medicine by translating bench discovery of biomarker technology into a pediatric multicenter clinical trial. Acute kidney injury (AKI) is a common complication of cardiopulmonary bypass (CPB), affecting adult and pediatric patients and significantly increasing the risk of mortality and medical services utilization. AKI treatment has traditionally been limited to supportive care or renal replacement therapy for severe cases. A major reason for treatment failure has been the unavoidable delay in initiating treatment secondary to lack of early biomarkers for AKI, akin to troponins in acute myocardial injury. Our research team identified neutrophil gelatinase-associated lipocalin (NGAL) as a diagnostic biomarker and showed that plasma and urine NGAL levels 2 hours after initiation of CPB reliably predict AKI development. Availability of a point-of-care (POC) NGAL test provides a means to diagnose AKI risk within an appropriate therapeutic "window of opportunity". Our central hypothesis is that early treatment of pediatric patients at risk for AKI based upon NGAL POC testing will reduce the incidence or mitigate the severity of AKI following CPB. We propose a randomized, double-blind trial comparing sodium bicarbonate (NaHCO3), the anti-oxidant N-acetylcysteine (NAC) or combination therapy to placebo in post-CPB pediatric patients, ages 1 month to 18 years, at risk for AKI based on early elevation of plasma NGAL. Assuming the participation of all 8 core PHN Centers with a conservative estimated minimum yearly volume of 200-250 eligible patients and a consent rate of 50%, study enrollment would be completed in 18- 23 months, allowing for analysis and dissemination of results within a 3 year time period.
RELEVANCE: AKI is relevant to public health as it is a common, clinically significant problem following CPB in patients of all ages. Use of a biomarker for assessment of AKI risk provides for the first time an opportunity for early intervention to reduce the incidence or mitigate the severity of AKI following CPB and thereby prevent associated morbidity and mortality. Thus, the proposed research is relevant to NIH's mission because it will provide fundamental knowledge necessary to reduce illness burden from AKI.
描述(由申请人提供):
该临床中心(Prairieland Consortium)是俄亥俄州辛辛那提儿童医院医疗中心和印第安纳州印第安纳波利斯莱利儿童医院儿科心血管项目的合作项目。儿科心脏网络 (PHN) 是一支杰出的研究团队,该联盟的合并患者群体每年有超过 500 例心脏直视手术和超过 20,000 例超声心动图,其先前在儿科心脏网络 (PHN) 的经验支持为 PHN 试验的患者招募做出重大贡献的能力。我们提出的临床试验通过将生物标志物技术的实验室发现转化为儿科多中心临床试验,解决了临床医学的一个重要差距。急性肾损伤(AKI)是体外循环(CPB)的常见并发症,影响成人和儿童患者,并显着增加死亡和医疗服务利用的风险。 AKI 治疗传统上仅限于对严重病例的支持治疗或肾脏替代治疗。治疗失败的一个主要原因是由于缺乏 AKI 早期生物标志物(类似于急性心肌损伤中的肌钙蛋白)而不可避免地延迟开始治疗。我们的研究小组确定中性粒细胞明胶酶相关脂质运载蛋白 (NGAL) 作为诊断生物标志物,并表明 CPB 开始后 2 小时血浆和尿液 NGAL 水平可以可靠地预测 AKI 的发展。 护理点 (POC) NGAL 检测的可用性提供了一种在适当的治疗“机会之窗”内诊断 AKI 风险的方法。我们的中心假设是,基于 NGAL POC 检测对有 AKI 风险的儿科患者进行早期治疗将降低 CPB 后 AKI 的发生率或减轻其严重程度。我们提出了一项随机、双盲试验,比较碳酸氢钠 (NaHCO3)、抗氧化剂 N-乙酰半胱氨酸 (NAC) 或联合疗法与安慰剂对 CPB 后儿科患者的影响,这些患者年龄为 1 个月至 18 岁,有 AKI 风险血浆 NGAL 的早期升高。假设所有 8 个核心 PHN 中心都参与其中,保守估计每年至少有 200-250 名合格患者,同意率为 50%,研究登记将在 18-23 个月内完成,从而可以在3年时间段。
相关性:AKI 与公共健康相关,因为它是所有年龄段患者 CPB 后常见的、具有临床意义的问题。使用生物标志物评估 AKI 风险首次提供了早期干预的机会,以减少 CPB 后 AKI 的发生率或减轻 AKI 的严重程度,从而预防相关的发病率和死亡率。因此,拟议的研究与 NIH 的使命相关,因为它将提供减少 AKI 疾病负担所需的基础知识。
项目成果
期刊论文数量(0)
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{{ truncateString('James Cnota', 18)}}的其他基金
Pediatric Heart Network Prairieland Consortium
儿科心脏网络 Prairieland 联盟
- 批准号:
10318624 - 财政年份:2017
- 资助金额:
$ 46.03万 - 项目类别:
Pediatric Heart Network Prairieland Consortium
儿科心脏网络 Prairieland 联盟
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10544155 - 财政年份:2017
- 资助金额:
$ 46.03万 - 项目类别:
Pediatric Heart Network Prairieland Consortium
儿科心脏网络 Prairieland 联盟
- 批准号:
9235494 - 财政年份:2017
- 资助金额:
$ 46.03万 - 项目类别:
Pediatric Heart Network Prairieland Consortium
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- 批准号:
10078967 - 财政年份:2017
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$ 46.03万 - 项目类别:
Administrative Coordinating Center: Bench to Bassinet Program
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10323291 - 财政年份:2016
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10571871 - 财政年份:2016
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$ 46.03万 - 项目类别:
Pediatric Heart Network Prairieland Consortium
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8181427 - 财政年份:2011
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$ 46.03万 - 项目类别:
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