MORTALITY AND MORBIDITY IN HEMODIALYSIS PATIENTS

血液透析患者的死亡率和发病率

• 批准号: 2145318
• 负责人: GERALD SCHULMAN
• 金额: $ 20.98万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-30 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2145318
• 关键词: blood chemistry; cardiovascular disorder; chronic renal failure; clinical trials; cooperative study; dosage; hemodialysis; hospital utilization; human morbidity; human mortality; human subject; human therapy evaluation; infection; longitudinal human study; renal rickets

DESCRIPTION (Directly taken from the application) The gross mortality of patients in the United States (U.S.) with end- stage renal disease (ESRD) treated by hemodialysis (HD) has increased over the past decade. Patients treated by HD have a life expectancy of only 20 percent of the general population at the current mortality rate. The variables associated with morbidity and mortality must include those which are treatment related (amount of dialysis delivered, membrane type) and those which are patient related (age, gender, comorbid illness), yet these variables have not been prospectively evaluated in a large population. The goal of this project is to conduct a prospective, multi-center, randomized clinical trial which will examine the impact of different levels of dialysis dose and membrane composition upon the mortality and morbidity of HD patients. The experimental design is a two-by-two factorial study. Following a series of screening tests, including assessing the ability of delivering the high dose level of dialysis to each prospective participant, participants will be randomized to receive one of two levels of dialysis as measured by 2- pool variable volume KT/V: 0.95 vs 1.4, and to be dialyzed against either low flux cellulosic membranes or high flux synthetic or semisynthetic membranes. Mortality in each of the four groups will be the primary outcome. A series of secondary outcomes including hospitalization frequency, assessment of infectious and cardiac complications, nutritional and general health and morbidity assessment will also be evaluated. Stop points include inadequate dialysis, adverse reaction to the dialysis membrane, transplantation and conclusion of the follow-up period.

描述（直接取自应用程序） 美国 (U.S.) 终末期患者的总死亡率 通过血液透析 (HD) 治疗的阶段性肾病 (ESRD) 有所增加 过去十年。 接受 HD 治疗的患者的预期寿命为 按照目前的死亡率计算，仅占总人口的 20%。 与发病率和死亡率相关的变量必须包括那些 与治疗相关（透析量、膜 类型）以及与患者相关的（年龄、性别、合并症） 疾病），但这些变量尚未在 人口众多。 该项目的目标是进行 前瞻性、多中心、随机临床试验将检查 不同水平透析剂量和膜成分的影响 HD 患者的死亡率和发病率。实验设计 是一项二乘二的析因研究。 经过一系列筛选测试后， 包括评估提供高剂量水平的能力 对每个潜在参与者进行透析，参与者将 随机接受两种透析水平之一（按 2- 测量） 池可变体积 KT/V：0.95 vs 1.4，并进行透析 低通量纤维素膜或高通量合成膜或 半合成膜。 四组中每一组的死亡率分别为 主要结果。 一系列次要结果包括 住院频率、感染性和心脏评估 并发症、营养和一般健康及发病率评估 也将被评估。 停止点包括透析不充分、不良 对透析膜的反应、移植和结论 随访期。