MORTALITY AND MORBIDITY IN HEMODIALYSIS

终末期肾病是一种灾难性的疾病。最近的报告表明 这种疾病的发病率正在以惊人的速度增长。 血液透析治疗终末期肾病可以挽救生命，但 40岁后的预期寿命约为正常人的1/4。 此外，尽管出现了高效、生物相容性 慢性透析患者的年死亡率 美国一直在增加，而且仍然比其他大多数国家高得多 工业化国家。目前尚不清楚透析量， 透析器生物相容性或两者都是造成这种情况的部分原因 死亡率上升。然而，一些研究表明，低剂量 通过单池尿素动力学模型使用Kt/V估计的透析的 与更高的死亡率相关。不幸的是， 透析的最佳剂量的不确定性。对RFA DK的回应- 94-004描述了我们作为临床中心的能力， 血液透析患者的死亡率和死亡率基于我们已证实的 在多中心临床试验中招募和管理患者的能力。的 研究将入组900例患者，这些患者将随机接受血液透析， 2池Kt/V为1.3-1.5或0.9-1.1，透析膜 生物相容的或生物不相容的。透析的剂量和输送 将通过每月测量Kt/V进行监测，Kt/V由2个池计算 模型此外，将监测尿素去除的直接测量。 结局变量为发病率和死亡率。 预计 这项研究将：1）提供信息，将提高生存 长期血液透析患者，2）提高估计 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.