MEDICAL MAINTENANCE OF HEMODIALYSIS VASCULAR ACCESS

终末期肾病(ESRD)是一种毁灭性的疾病，在美国，每年有超过8万名新患者需要开始治疗ESRD。这些患者中的大多数将接受血液透析形式的维持生命治疗。不幸的是，血液透析患者的生活质量和持续时间受到血管通路的严重限制。最近的观察表明，在ESRD人群中，近25%的住院与血管通路有关，而血管通路引起的问题每年花费近10亿美元。血管通路衰竭是ESRD发病的最重要的可逆原因。本申请是对RFA DK-00-012的响应，描述了我们作为血液透析血管通路联盟临床中心的能力。我们在招募和参与类似的肾病多中心试验方面有着良好的记录，因为我们目前是非裔美国人肾脏疾病和高血压研究(AASK)、发病率和死亡率以及血液透析(HEMO)试验的大型临床站点。我们建议在PTFE移植物中使用细胞周期抑制剂西罗莫司(雷帕霉素)进行预防试验。我们将从我们的2000多名血液透析患者中招募人才，我们将与数据协调中心和其他网站合作，设计和进行一系列多中心、随机、安慰剂对照的治疗临床试验，以在5年内降低血液透析患者动静脉瓣和瘘的并发症发生率。我们预计，该联盟将能够开发管理血液透析血管通路的新方法，这些新疗法可以降低美国ESRD人群的血液透析护理的成本和并发症。

End-stage renal disease (ESRD) is a devastating illness, and each year in the United States more than 80,000 new patients need initiation of therapy for ESRD. The majority of these patients will receive life-sustaining treatments in the form of hemodialysis. Unfortunately, the quality and duration of the lives of patients on hemodialysis are severely restricted by vascular access. Recent observations suggest that nearly 25% of hospitalizations in the ESRD population are related to vascular access, and problems that emanate from vascular access cost nearly $1 billion annually. Vascular access failure is arguably the most important reversible cause of morbidity in ESRD. This application is in response to RFA DK-00-012 and describes our competence to serve as a clinical center in the Hemodialysis Vascular Access Consortium. We have a strong track record in recruiting for and participating in similar multicenter trials in Nephrology, since we currently serve as large clinical sites for the African American Study of Kidney Disease and Hypertension (AASK) and the Morbidity and Mortality and in Hemodialysis (HEMO) trials. We propose a prevention trial with the cell cycle inhibitor Sirolimus (Rapamycin) in PTFE grafts. We will recruit from our pool of more than 2000 hemodialysis patients, and we will work with the Data Coordinating Center and the other sites to design and conduct a series of multicenter, randomized, placebo-controlled clinical trials of therapies to reduce the complication rate of AV grafts and fistulas in hemodialysis patients over a 5-year period. We anticipate that this consortium will be able to develop new approaches to managing hemodialysis vascular access, and that these new treatments can decrease the costs and complications of hemodialysis care of the US ESRD population.