Determinants of Hemodialysis AV Fistula Maturation

血液透析动静脉瘘成熟的决定因素

基本信息

批准号：
7547242
负责人：
Laura M Dember
金额：
$ 35.6万
依托单位：
BOSTON MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-09-10 至 2013-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7547242
关键词：
Agreement American Anastomosis - action Anatomy Ancillary Study Angiography Arteries Arteriovenous fistula Bacteremia Biological Markers Blood Vessels Blood flow Blood specimen Boston Catheters Central Vein Cessation of life Characteristics Clinical Clinical Practice Guideline Clinical Trials Cohort Studies Data Data Collection Development Dialysis procedure Digital Photography Early identification End stage renal failure Enrollment Evaluation Expenditure Failure Fistula Frequencies Funding Future Healthcare Hemodialysis Histologic Hospitalization Hyperplasia In Vitro Individual Infection Inflammation Information Systems Intervention Kidney Kinetics Leadership Lesion Maintenance Measurement Measures Mediating Methods Modification Morbidity - disease rate National Institute of Diabetes and Digestive and Kidney Diseases Nitric Oxide Numbers Operative Surgical Procedures Outcome Participant Patients Performance Phenotype Physical Dialysis Physical Examination Physiologic arteriovenous anastomosis Physiological Plasma Policies Prevalence Procedures Process Rate Relative (related person)Repeat Surgery Research Research Infrastructure Research Personnel Resolution Resources Second Look Surgery Site Stem cells Stenosis Techniques Testing Thrombosis Time Ultrasonography United States Universities Vasodilation Veins Venous Week Work base cell growth clinical application cohort day design in vitro Assay in vivo insight member multidisciplinary programs response size success tonometry

项目摘要

DESCRIPTION (provided by applicant): Approximately 470,000 Americans have end-stage renal disease and most are treated with hemodialysis. A vascular access is required for performing the hemodialysis procedure and can be provided with a native arteriovenous (AV) fistula, a synthetic AV graft; or a central venous catheter. The AV fistula is the preferred type of vascular access because thrombosis rates, infection rates, access-related expenditures, and total healthcare expenditures all are lower for patients with fistulas than for those with either synthetic AV grafts or central venous catheters. However, the advantages of fistulas are counterbalanced by the substantially higher proportion of fistulas than grafts that are never able to be used for dialysis because of failure to mature adequately to support effective hemodialysis. Maturation failure is the major barrier to increasing fistula prevalence, and, for many patients, leads to multiple surgical procedures or prolonged use of central venous catheters, the least desirable type of vascularaccess. Recent studies suggest that 20-50% of new fistulas fail to mature. This application is a response to an NIDDK RFA to establish a consortium for designing and performing an observational cohort study of patients with new fistulas. We are applying to be one of the Participating Clinical Centers of the Consortium. The overall objective of this application is to identify determinants of fistula maturation outcomes in order to enable early identification of failing fistulas, elucidate mechanisms underlying fistula maturation, and identify potential targets for maturation-enhancing interventions. Our application has five specific aims. These include 1) determining the utility of ultrasound as a method for early identification of fistulas that are failing to mature, 2) evaluating the impact of pre-existing vascular function on fistula maturation outcomes, 3) identifying surgical factors that are associated with fistula maturation outcomes, 4) creating evidence-based criteria for fistula maturation, and 5) characterizing the clinical consequences of fistula maturation failure. These aims assume an enrollment of 75-100 subjects over two years at our site for an overall study cohort of 600 subjects. Several of our aims include sub-studies that will be performed in a subset of the subjects to provide additional mechanistic information about the fistula maturation process. Our established research focus and expertise in hemodialysis vascular access, our success and leadership as a Clinical Center for the NIDDK Dialysis Access Consortium (DAC), the multidisciplinary expertise of the collaborators for this application, and the resources available at Boston University make us ideally suited to serve as a Participating Clinical Center for this NIDDK initiative.

描述（由申请人提供）：大约 470,000 名美国人患有终末期肾病，其中大多数接受血液透析治疗。进行血液透析程序需要血管通路，并且可以提供天然动静脉 (AV) 瘘管、合成 AV 移植物；或中心静脉导管。 AV 瘘管是首选的血管通路类型，因为瘘管患者的血栓形成率、感染率、通路相关支出和总医疗支出均低于使用合成 AV 移植物或中心静脉导管的患者。然而，瘘管的优点被比移植物高得多的瘘管比例所抵消，因为移植物由于未能充分成熟以支持有效的血液透析而永远无法用于透析。成熟失败是增加瘘管患病率的主要障碍，并且对于许多患者来说，导致多次外科手术或长时间使用中心静脉导管，这是最不理想的血管通路类型。最近的研究表明，20-50% 的新瘘管未能成熟。该申请是对 NIDDK RFA 的回应，旨在建立一个联盟，用于设计和执行新发瘘管患者的观察性队列研究。我们正在申请成为该联盟的参与临床中心之一。该应用的总体目标是确定瘘管成熟结果的决定因素，以便能够及早识别失败的瘘管，阐明瘘管成熟的潜在机制，并确定促进成熟的干预措施的潜在目标。我们的应用程序有五个具体目标。其中包括 1) 确定超声作为早期识别未成熟瘘管的方法的效用，2) 评估现有血管功能对瘘管成熟结果的影响，3) 确定与瘘管成熟相关的手术因素结果，4) 制定基于证据的瘘管成熟标准，以及 5) 描述瘘管成熟失败的临床后果。这些目标假设我们的研究中心两年内招募了 75-100 名受试者，整个研究队列共有 600 名受试者。我们的几个目标包括将在一部分受试者中进行的子研究，以提供有关瘘管成熟过程的额外机制信息。我们在血液透析血管通路方面的既定研究重点和专业知识、我们作为 NIDDK 透析通路联盟 (DAC) 临床中心的成功和领导地位、该应用合作者的多学科专业知识以及波士顿大学的可用资源，使我们成为理想的选择作为 NIDDK 倡议的参与临床中心。