MORTALITY AND MORBIDITY IN HEMODIALYSIS

终末期肾病是一种灾难性的疾病。最近的报告显示 这种疾病的发生率正在以惊人的速度增长。 血液透析治疗终末期肾病是挽救生命的，但生命- 40岁以后，人们的预期寿命大约是正常人的四分之一。 此外，尽管出现了高效、生物兼容的 年慢性透析患者血液透析器年死亡率 美国一直在增长，而且仍然远远高于其他大多数国家 工业化国家。目前尚不清楚透析量， 透析器的生物兼容性或两者兼而有之是造成这一现象的部分原因 死亡率的增加。然而，几项研究表明，低剂量的 用Kt/V的单池尿素动力学模型估算的透析量为 与更高的死亡率相关。不幸的是，有相当多的 关于最佳透析剂量的不确定性。以下是对RFA DK的回应- 94-004描述了我们作为临床中心的能力 基于我们已证实的血液透析患者的死亡率和发病率 在多中心临床试验中招募和管理患者的能力。这个 这项研究将招募900名患者，他们将被随机分配到血液透析组， 1.3-1.5或0.9-1.1的两池Kt/V和透析膜 要么是生物相容，要么是生物不相容。透析的剂量和投放 将通过每月测量2池计算的Kt/V进行监控 模特。此外，还将监测尿素清除的直接测量。 结果变量将是发病率和死亡率。这是意料之中的 这项研究将：1)提供将提高患者存活率的信息 长期血液透析患者和2)提高估计能力 透析剂量和透析膜对存活率的影响。

End-stage renal disease is a catastrophic illness. Recent reports indicate that the incidence of this disorder is increasing at an alarming rate. Treatment of ESRD with hemodialysis is life-saving, however life- expectancy is about 1/4 that of normal individuals after age 40. Furthermore, despite the advent of high-efficiency, biocompatible hemodialyzers, annual mortality rate of patients on chronic dialysis in the U.S. has been increasing and remains much higher than most other industrialized nations. It is not known whether the amount of dialysis, dialyzer biocompatibility or both are in part responsible for this increase in mortality. However, several studies have shown that a low dose of dialysis, estimated by single-pool urea kinetic models using Kt/V, is associated with a higher mortality. Unfortunately, there is considerable uncertainty as to the optimal dose of dialysis. This response to RFA DK- 94-004 describes our competence to serve as a clinical center for the Mortality and Morbidity in Hemodialysis Patients based on our proven ability to recruit and manage patients in multicenter clinical trials. The study will enroll 900 patients who will be randomized to hemodialysis with a 2-pool Kt/V of either 1.3-1.5 or 0.9-1.1 and a dialysis membrane that is either biocompatible or bioincompatible. The dose and delivery of dialysis will be monitored by monthly measurement of Kt/V calculated by a 2-pool model. In addition direct measurement of urea removal will be monitored. The outcome variables will be morbidity and mortality. It is anticipated that this study will: 1) provide information that will improve survival of patients on long-term hemodialysis and 2) improve the ability to estimate the effects of dialysis dose and dialysis membrane on survival.