MORTALITY AND MORBIDITY IN HEMODIALYSIS--CLINICAL CENTER

血液透析中的死亡率和发病率--临床中心

• 批准号: 2518441
• 负责人: DANIEL B. ORNT
• 金额: $ 22.56万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 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
• 来源: https://reporter.nih.gov/project-details/2518441
• 关键词: biomaterial evaluation; blood chemistry; cardiovascular disorder; chronic renal failure; clinical trials; cooperative study; hemodialysis; human morbidity; human mortality; human subject; human therapy evaluation; medical complication; quality of life

The population of patients entering the End-Stage Renal Disease (ESRD) Program in the United States (US) has grown each year since inception of Federal funding for the program. In 1990 the estimated cost to Medicare was over $5 billion and nearly 200,000 patients were receiving treatment. The major modality of therapy for this population is in-center hemodialysis (HD). Recent analysis of the HD population in the US has revealed disturbingly high mortality rates (23.4%) and marked reduction in life expectancy compared to the general population. Other countries have reported much lower mortality rates in their HD populations. Whether the US HD population can be compared to that of other countries remains a question. Reports from other countries reveal the amount or adequacy of HD received by patients tends to be greater than in the US. This fact raises the question whether adequacy of HD is a major contributor to the excess mortality of US patients. The NIH has instituted a major study to address these issues called the Mortality and Morbidity in HD (MMHD) Study. This is a five year multi-center study of patients randomly assigned to l of 4 different HD prescriptions. The different prescriptions for this study include varying adequacy of HD (KT/V of l versus KT/V of 1.4) and two different hemodialyzer membranes (a bioincompatible versus biocompatible membrane). Thus, patients will be randomized to l of 4 different protocols. Mortality will be measured as well as secondary outcomes such as hospitalizations and quality of life. This proposal is to apply to become 1 of 15 "Clinical Centers" for this study. This application demonstrates that the University of Rochester has the expertise and a sufficient HD patient population to satisfactorily recruit patients and complete this study.

进入终末期肾病(ESRD)患者的人群 自成立以来，美国的计划每年都在增长 联邦政府为该项目提供资金。在1990年，医疗保险的估计成本 超过50亿美元，近20万名患者正在接受治疗。 这一人群的主要治疗方式是中心治疗。 血液透析(HD)。最近对美国HD人群的分析显示 显示出令人不安的高死亡率(23.4%)和明显的减少 与一般人口相比的预期寿命。其他国家也有 报告说，他们的HD人群的死亡率要低得多。无论是 美国的HD人口可以与其他国家的人口相比 问题。来自其他国家的报告揭示了 患者接受的HD往往比美国更大。这一事实 令人质疑房屋署的充足程度是否是导致 美国患者的超额死亡率。美国国立卫生研究院开展了一项重大研究，以 解决这些称为HD死亡率和发病率(MMHD)的问题 学习。这是一项为期五年的多中心随机研究。 给L分配了4种不同的HD处方。不同的药方 本研究包括不同的HD充分性(L的KT/V与 1.4)和两种不同的血液透析膜(生物不相容与 生物相容膜)。因此，患者将被随机分配到4岁的L 不同的协议。死亡率将被衡量为次要的 结果，如住院和生活质量。 这项提案将申请成为15个临床中心之一 学习。这份申请证明了罗切斯特大学已经 专业知识和足够的HD患者人数令人满意 招募病人并完成这项研究。