AKI Matched Phenotype Linked Evaluation with Tissue (AMPLE-Tissue)
AKI 匹配表型相关组织评估 (AMPLE-Tissue)
基本信息
- 批准号:9911045
- 负责人:
- 金额:$ 30万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-07-01 至 2022-06-30
- 项目状态:已结题
- 来源:
- 关键词:AcuteAcute Renal Failure with Renal Papillary NecrosisAnimal ModelAnimalsBiopsyBrain DeathCessation of lifeClinicalClinical TrialsClinical Trials Data Monitoring CommitteesCollectionCommunitiesComplexComputerized Medical RecordConsentCore BiopsyCritical IllnessDataData LinkagesData QualityDialysis procedureEnrollmentEquilibriumEthicsEtiologyEvaluationEventExcisionFamilyFundingHealth Care CostsHemorrhageHepatorenal SyndromeHistologicHospitalizationHumanHuman CharacteristicsIncidenceIntensive Care UnitsInterventionKidneyKidney DiseasesKidney TransplantationLeadLinkLiving DonorsLongterm Follow-upMedicalMedical RecordsMolecularMolecular TargetMonitorMorbidity - disease rateNephrectomyParticipantPathologyPathway interactionsPatient MonitoringPatientsPercutaneous NephrostomyPersonsPhasePhenotypePopulationProspective StudiesRenal Cell CarcinomaRenal functionReproducibilityResearchRiskRisk FactorsSafetySamplingSelection BiasSeveritiesSiteSystemTelephoneTimeTissuesTransfusionTranslational ResearchUnited States National Institutes of HealthVisitadministrative databaseadverse outcomebaseclinically significantcohortcostdata sharingelectronic dataendophenotypeexperiencefollow-uphuman diseasehuman tissuekidney biopsyliver transplantationmortalitynovelnovel markerpatient safetyprecision medicineprogramspublic health relevancerecruitresearch studyresponsespecific biomarkerstargeted treatmenttherapeutic targeturinary tract obstruction
项目摘要
Abstract
Acute kidney injury (AKI) is a common condition and is associated with both short- and long-term adverse
outcomes in those who develop it. Translational research studies of actual human kidney tissue during an AKI
event can lead to discovery of novel AKI pathways and therapeutic targets.
In response to the RFA-DK-16-026, also known as the Kidney Precision Medicine Program, our proposal aims
to safely and ethically enroll a diverse group of participants with AKI. Our proposal aims to balance the need
for obtaining kidney tissue from a diverse AKI population with the risks of obtaining this tissue. Kidney biopsies
carry a small but significant risk of bleeding which may be somewhat increased in the setting of AKI.
In the AKI Matched Phenotype Linked Evaluation with Tissue (AMPLE-Tissue) Study, we propose that the
optimal way to obtain tissue in AKI patients would be through a combination of approaches. First, we will obtain
extra tissue at the time of clinically indicated kidney biopsies, since prior data suggests that this approach does
not add additional bleeding risk. We will carefully select participants who are at lower risk of bleeding. Over the
last two years, we have enrolled over 200 participants in a research study and collected kidney biopsies from
them. Over 70% of these participants said that they would be willing to donate extra tissue for research.
Second, to encompass the whole AKI spectrum from its mildest to severest forms, we will also biopsy kidneys
in deceased donors. The causes of AKI in deceased donors are similar to those experienced by critically ill AKI
patients. Obtaining biopsies in this setting is low-risk; we have successfully enrolled over 900 deceased
patients who received kidney biopsies in an ongoing NIH-funded project. Third, we will obtain research-only
biopsies in specially-selected settings of hepatorenal syndrome and obstructive kidney disease when bleeding
risk is low.
In the UG3 phase, our aim is to obtain biopsies from 90-100 participants over two years and closely monitor
patient safety. We will establish a community advisory board of AKI patients in addition to a data and safety
monitoring board for the study. We will share data within the consortium after removal of patient identifiers. We
will also establish linkages with various electronic medical record system as well as administrative databases
to streamline follow-up. In the UH3 phase, we will expand our study to other sites and settings based on the
biopsy quality and safety data from UG3 phase and enroll 375 participants over three years. We will also
conduct longitudinal follow-up on all participants using various mechanisms which were effective for us in the
past.
摘要
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
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Chirag R Parikh其他文献
Attempts To Achieve Standardized Definitions To Characterize Changes In Kidney Function In The Context Of Heart Failure Clinical Trials: From The Heart Failure Collaboratory
在心力衰竭临床试验中尝试实现标准化定义以表征肾功能变化:来自心力衰竭协作组
- DOI:
10.1016/j.cardfail.2024.10.106 - 发表时间:
2025-01-01 - 期刊:
- 影响因子:8.200
- 作者:
Isabella Cavagna;Anu Lala;Carine Hamo;Mona Fiuzat;Steven Coca;William Abraham;Christopher O'Connor;JoAnn Lindenfeld;James Januzzi;Mark Sarnak;Chirag R Parikh;Wendy McCallum;Marvin Konstam;Maria Rosa Costanzo - 通讯作者:
Maria Rosa Costanzo
Reversal of end-stage renal disease after aortic dissection using renal artery stent: a case report
- DOI:
10.1186/1471-2369-5-7 - 发表时间:
2004-05-04 - 期刊:
- 影响因子:2.400
- 作者:
Andrew S Weiss;Michael Ludkowski;Chirag R Parikh - 通讯作者:
Chirag R Parikh
Chirag R Parikh的其他文献
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{{ truncateString('Chirag R Parikh', 18)}}的其他基金
Post-Discharge Nephrology Follow-up for Improved Outcomes
出院后肾脏病学随访以改善结果
- 批准号:
10451808 - 财政年份:2021
- 资助金额:
$ 30万 - 项目类别:
Post-Discharge Nephrology Follow-up for Improved Outcomes
出院后肾脏病学随访以改善结果
- 批准号:
10296363 - 财政年份:2021
- 资助金额:
$ 30万 - 项目类别:
Post-Discharge Nephrology Follow-up for Improved Outcomes
出院后肾脏病学随访以改善结果
- 批准号:
10670199 - 财政年份:2021
- 资助金额:
$ 30万 - 项目类别:
AKI Matched Phenotype Linked Evaluation with Tissue (AMPLE-Tissue)
AKI 匹配表型相关组织评估 (AMPLE-Tissue)
- 批准号:
10225441 - 财政年份:2018
- 资助金额:
$ 30万 - 项目类别:
AKI Matched Phenotype Linked Evaluation with Tissue (AMPLE-Tissue)
AKI 匹配表型相关组织评估 (AMPLE-Tissue)
- 批准号:
10493566 - 财政年份:2017
- 资助金额:
$ 30万 - 项目类别:
AKI Matched Phenotype Linked Evaluation with Tissue (AMPLE-Tissue)
AKI 匹配表型相关组织评估 (AMPLE-Tissue)
- 批准号:
10703455 - 财政年份:2017
- 资助金额:
$ 30万 - 项目类别:
Novel Kidney Injury Tools in Deceased Organ Donation to Predict Graft Outcomes
死亡器官捐赠中预测移植结果的新型肾损伤工具
- 批准号:
10177020 - 财政年份:2012
- 资助金额:
$ 30万 - 项目类别:
Novel Kidney Injury Tools in Deceased Organ Donation to Predict Graft Outcome
死亡器官捐赠中预测移植结果的新型肾损伤工具
- 批准号:
8370601 - 财政年份:2012
- 资助金额:
$ 30万 - 项目类别:
Mentoring Program for Translational and Patient Oriented Research in AKI
AKI 转化和以患者为导向的研究指导计划
- 批准号:
8607937 - 财政年份:2012
- 资助金额:
$ 30万 - 项目类别:
Novel Kidney Injury Tools in Deceased Organ Donation to Predict Graft Outcome
死亡器官捐赠中预测移植结果的新型肾损伤工具
- 批准号:
9233645 - 财政年份:2012
- 资助金额:
$ 30万 - 项目类别: