MORBIDITY AND MORTALITY IN HEMODIALYSIS PATIENTS

这是杜克大学肾脏科的申请 大学医学中心作为NIH的临床中心参与 赞助的合作研究，旨在降低 终末期肾病患者。 该提案专门针对 对接受中心血液透析的患者，符合标准 美国国立卫生研究院（NIH）指南中题为“ 血液透析患者”。 本试验是一项前瞻性、多中心、随机、2 × 2析因试验， 设计的临床试验。这项试验旨在比较两种不同的 血液透析膜的类别和两个水平的输送透析 （由公式Kt/V定义，其中K是透析器尿素清除率， ml/min，t是以分钟为单位的治疗时间，V是体内尿素体积 以毫升计）对患者发病率和死亡率的影响。Kt/V交付 50%患者的透析目标为0.9-1.1。Kt/V交付 50%患者的透析目标为1.3-1.5。中的每一个内 这些输送透析组中50%的患者将接受透析， 高通量、生物相容性透析膜，50%将被透析 低通量生物不相容的纤维素膜的目标 该研究旨在降低血液透析患者死亡率和发病率。 干预措施将是输送的透析量和 使用透析膜。所有原因造成的死亡率将是 主要成果。次要结局包括非血管入路率- 相关入院、心血管事件、充血性心脏 失败、感染的发生和血清白蛋白的下降。的作用 透析量和透析膜类型应 在审判结束前就能看出来杜克大学透析系统 拟入组60例患者进入该多中心方案，并遵守 操作手册的所有方面。

This is an application from the Division of Nephrology at the Duke University Medical Center to participate as a clinical center in a NIH sponsored cooperative study aimed at reducing morbidity and mortality in patients with end-stage renal disease. This proposal focuses exclusively on patients receiving incenter hemodialysis and conforms to the criteria set forth in the NIH Guide entitled "Morbidity and Mortality in Hemodialysis Patients". This trial is a prospective, multicenter, randomized, 2 X 2 factorial designed clinical trial. This trial is designed to compare two different classes of hemodialysis membranes and two levels of delivered dialysis (defined by the formula Kt/V, where K is the dialyzer urea clearance in ml/min, t is the treatment time in minutes, and V is the body urea volume in milliliters) on patient morbidity and mortality. The Kt/V delivered dialysis target in 50% of the patients will be 0.9-1.1. The Kt/V delivered dialysis target in the 50% of the patients will be 1.3-1.5. Within each of these delivered dialysis groups 50% of the patients will be dialyzed with a high-flux, biocompatible, dialysis membrane and 50% will be dialyzed with a low-flux, bioincompatible cellulosic membrane. The objectives of the study are to reduce mortality and morbidity in hemodialysis patients. The interventions will be the amount of delivered dialysis and the dialysis membrane employed. Mortality due to all causes will be the primary outcome. Secondary outcomes include rate of nonvascular access- related hospital admission, cardiovascular events, congestive heart failure, occurrence of infections, and decline in serum albumin. The role of the amount of delivered dialysis and the type dialysis membrane should be apparent by the end of the trial. The Duke University dialysis system proposes to enroll 60 patients into this multicenter protocol and comply with all aspects of the manual of operations.