MORBIDITY AND MORTALITY IN HEMODIALYSIS PATIENTS

这是杜克大学肾病学部的申请书 大学医学中心将作为临床中心参加美国国立卫生研究院 受赞助的合作研究旨在减少#年的发病率和死亡率 终末期肾病患者。这项提案专门关注 浅谈中心内血液透析患者及符合标准 在《美国国立卫生研究院指南》中提出了《年发病率和死亡率 血液透析患者“。 这是一项前瞻性、多中心、随机、2×2因素的试验 设计临床试验。这项试验旨在比较两种不同的 血液透析膜的分类和两级输送透析器 (由公式Kt/V定义，其中K为透析器尿素清除量 Ml/min，t为治疗时间，单位为分钟，V为体内尿素体积 毫升)对患者发病率和死亡率的影响。交付的Kt/V 50%的患者的透析目标将在0.9-1.1。交付的Kt/V 透析指标将在50%的患者中为1.3-1.5。在每个 这些交付的透析组将对50%的患者进行透析 一种高通量、生物相容的透析膜和50%将被透析 使用低通量、生物不相容的纤维素膜。的目标 这项研究旨在降低血液透析患者的死亡率和发病率。 干预措施包括提供的透析量和 使用透析膜。所有原因造成的死亡将是 主要结果。次要结果包括非血管通畅率- 相关住院、心血管事件、充血性心脏病 衰竭、感染的发生和血清白蛋白的下降。角色 透析量和透析膜的类型应 在审判结束时表现得很明显。杜克大学的透析系统 建议将60名患者纳入这一多中心方案并遵守 操作手册的方方面面。

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.