MORTALITY AND MORBIDITY IN HEMODIALYSIS STUDY PROTOCOL

血液透析研究方案中的死亡率和发病率

基本信息

  • 批准号:
    2770496
  • 负责人:
  • 金额:
    $ 23.56万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    1994
  • 资助国家:
    美国
  • 起止时间:
    1994-09-30 至 2001-08-31
  • 项目状态:
    已结题

项目摘要

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.
美国血液透析患者的年总死亡率约为24%, 不可接受的高。死亡率差异的确切原因可能是 与输送的透析量有关。适当的定义 源自NCDS的透析不适用于当今的老年患者 合并症更多,以及当前的透析条件, 透析器重复使用是普遍的。传统的计算方法 关键变量,每次透析的总尿素清除率标准化为 尿素的分布体积(KT/V),可能不足以假设 一个单一的分配池。影响力的代价更大,但 生物相容性高通量透析器尚未解决。最后,影响 严格监测透析输送和实施标准, 对患者生存、发病率、康复的一般医疗护理,以及 遵守情况不明。由于这些关键的缺陷, 知识的照顾美国人与ESRD,我们建议作为一个 “临床中心”与MDDK和其他 在死亡率和死亡率评估的全面阶段, 血液透析患者试验,定义见 12/23/93.在这项前瞻性、多中心、随机、两对两的研究中, 析因试验,我们建议高输送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。这些干预措施是: (1)通过两个样本池分布容积计算KT/V 制剂,和(2)大分子量的并行透析器通量 重量溶质及其生物相容性。对于KT/V组件, 目标值为1.4(范围为1.3至1.5)和1.0(0.9至1.1), 通过Smye方法、巴克斯特或Fresenius透析计算 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β 2-MG筛分系数的函数定义, 以及透析中中性粒细胞减少症和补体生成。分别的 主要结局是患者的死亡率,次要结局是 结果将是住院率和频率的非访问 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 回收适当的血液样本,给药和 检索问卷,监测临床状态, 病人和维护他们的健康,记录该协议是 患者和透析设施严格遵守, 替换死亡或退出研究的患者, 将适当的血液和尿液样本送至中心生化实验室 并将检测结果和信息反馈给DCC,监控当地质量 控制,并参与所有联合中心和委员会 活动

项目成果

期刊论文数量(0)
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EDGAR L MILFORD其他文献

EDGAR L MILFORD的其他文献

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{{ truncateString('EDGAR L MILFORD', 18)}}的其他基金

MORTALITY AND MORBIDITY IN HEMODIALYSIS STUDY PROTOCOL
血液透析研究方案中的死亡率和发病率
  • 批准号:
    6380958
  • 财政年份:
    1994
  • 资助金额:
    $ 23.56万
  • 项目类别:
MORTALITY AND MORBIDITY IN HEMODIALYSIS STUDY PROTOCOL
血液透析研究方案中的死亡率和发病率
  • 批准号:
    2905714
  • 财政年份:
    1994
  • 资助金额:
    $ 23.56万
  • 项目类别:
MORTALITY AND MORBIDITY IN HEMODIALYSIS STUDY PROTOCOL
血液透析研究方案中的死亡率和发病率
  • 批准号:
    6177331
  • 财政年份:
    1994
  • 资助金额:
    $ 23.56万
  • 项目类别:
UNIQUE CLASS II ANTIGENS IN NARCOLEPTICS
嗜睡症中独特的 II 类抗原
  • 批准号:
    3933842
  • 财政年份:
  • 资助金额:
    $ 23.56万
  • 项目类别:
UNIQUE CLASS II ANTIGENS IN NARCOLEPTICS
嗜睡症中独特的 II 类抗原
  • 批准号:
    3956531
  • 财政年份:
  • 资助金额:
    $ 23.56万
  • 项目类别:
UNIQUE CLASS II ANTIGENS IN NARCOLEPTICS
嗜睡症中独特的 II 类抗原
  • 批准号:
    3912748
  • 财政年份:
  • 资助金额:
    $ 23.56万
  • 项目类别:

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