MORTALITY AND MORBIDITY IN HEMODIALYSIS STUDY PROTOCOL

美国血液透析患者每年约24%的总死亡率为 高得令人无法接受。死亡率出现这种差异的确切原因可能是 与提供的透析量有关。适足的定义 非传染性疾病衍生的透析不适用于今天的老年患者 有更多的并存，以及目前的透析条件 透析器的重复使用很普遍。传统的计算方法不同于传统的 临界变量，归一化的每次透析的总尿素清除量 尿素的分配体积(KT/V)可能不足以满足其假设 一个单一的分配池。成本更高的影响，但 生物相容的高通量透析器尚未解决。最后， 严格监测透析的提供和标准的实施 关于患者生存、发病率、康复和 合规性尚不清楚。由于这些严重的缺陷， 对于患有ESRD的美国人的护理知识，我们建议作为一个 与MDDK和其他机构达成合作协议的“临床中心” 年死亡率和发病率处于全面阶段的核准中心 血液透析患者试验定义在《研究方案》中 12/23/93。在这个前瞻性的、多中心的、随机的、2乘2的 析因试验，我们建议高释放KT/V和(或)透析 使用生物相容的高通量膜材料将减少患者 死亡率和发病率。干预措施包括： (1)按两池分配容量计算的KT/V 配方；(2)大分子的并发透析剂通量 重量溶质及其生物相容性。对于KT/V组件， 目标值1.4(范围1.3到1.5)和1.0(0.9到1.1)将为 由Smye方法、Baxter或Fresenius Dianalysis计算 取样器法，或30分钟回弹法。另一个变量将 透析膜的通量和生物相容性， 基于β2-MG筛选系数的函数定义， 以及透析中的中性粒细胞减少和补体生成。分别进行了分析。这个 主要结果将是患者的死亡率，次要结果是 结果将是不能进入的住院率和频率 相关问题，心脏病和感染，以及 血清白蛋白浓度。我们将负责及时的 取回适当的血液样本，给药和 收回问卷，监测患者的临床状态 患者和维护他们的健康，记录该方案是 得到患者和透析机构的严格遵守， 替换死亡或退出研究的患者，将 适当的血液和尿液样本送往中心生化实验室 并将检测结果和信息提供给DCC，监测当地质量 控制和参与所有连体中心和委员会 活动。

The approximate 24% annual gross mortality of US hemodialysis patients is unacceptably high. The precise reason for this variance in mortality may relate to the quantity of dialysis delivered. The definition of adequate dialysis derived from the NCDS is inapplicable to today's older patients with more co-morbidity, and to current dialysis conditions in which dialyzer reuse is prevalent. The conventional methods for calculating the critical variable, the total urea clearance per dialysis normalized for urea's distribution volume (KT/V), may be inadequate in its assumption of a single pool of distribution. The influence of the more costly, but biocompatable, high flux dialyzers is unresolved. Lastly, the impact of rigorous monitoring of dialysis delivery and the practice of standards for general medical care on patient survival, morbidity, rehabilitation, and compliance is unknown. Because of these critical deficiencies in the knowledge for the care of Americans with ESRD, we propose to serve as a "Clinical Center" in cooperative agreement with the MDDK and with other approved Centers in the full-scale phase of the Mortality and Morbidity in Hemodialysis Patients Trial as defined in the "Study Protocol" of 12/23/93. In this prospective, multicenter, randomized, two-by-two factorial trial, we propose that a high delivered KT/V and (or) dialysis with a biocompatable, high flux membrane material will reduce patient mortality and morbidity. The interventions are: (1) the KT/V as calculated by a two pool volume of distribution formulation, and (2) the concurrent dialyzer flux for large molecular weight solutes and its biocompatability. For the KT/V component, the target values of 1.4 (range of 1.3 to 1.5) and 1.0 (0.9 to 1.1) will be calculated by either the Smye method, the Baxter or Fresenius Dialysis Sampler method, or the 30 minute rebound method. The other variable will be the flux capacity and the biocompatability of the dialysis membrane, based upon a functional definitions of the beta2-MG sieving coefficient, and intradialytic neutropenia and complement generation. respectively. The primary outcome will be the patients' death rate, and the secondary outcomes will be the hospitalization rate and frequency for non-access related problems, cardiac disease, and infections, and a decline in the serum albumin concentration. We will be responsible for the timely retrieval of the appropriate blood samples, the administration and retrieval of questionnaires, monitoring the clinical status of the patients and maintaining their health, documenting that the protocol is being strictly adhered to by the patients and the dialysis facilities, replacing patients that die or who drop out of the study, transmitting the appropriate blood and urine samples to the Central Biochemistry Laboratory and the test results and information to the DCC, monitoring local quality control, and participating in all conjoined Center and Committee activities.