MORTALITY AND MORBIDITY IN HEMODIALYSIS PATIENTS

血液透析患者的死亡率和发病率

• 批准号: 2905525
• 负责人: GERALD SCHULMAN
• 金额: $ 25.96万
• 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/2905525
• 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.）患者的总死亡率在结束- 通过血液透析（HD）治疗的晚期肾病（ESRD）增加 在过去的十年里。 接受HD治疗的患者的预期寿命为 在目前的死亡率下，只有20%的人口。 与发病率和死亡率相关的变量必须包括 与治疗相关（输送的透析量、膜 类型）和患者相关（年龄、性别、共病 疾病），但这些变量尚未进行前瞻性评估， 人口众多。 该项目的目标是进行一项 前瞻性、多中心、随机临床试验， 不同水平透析剂量和膜组成的影响 HD患者的死亡率和发病率。实验设计 是一个二乘二的析因研究。 经过一系列的筛选测试， 包括评估递送高剂量水平的 为每名潜在参与者进行透析，参与者将 随机接受两个水平透析之一，通过2- 合并液可变容量KT/V：0.95 vs 1.4，并根据 低通量纤维素膜或高通量合成膜， 半合成膜 四组中每组的死亡率为 主要成果。 一系列次要结局，包括 住院频率、感染性和心脏病评估 并发症、营养和一般健康及发病率评估 也将进行评估。 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。