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MORTALITY AND MORBIDITY IN HEMODIALYSIS PATIENTS

MORTALITY AND MORBIDITY IN HEMODIALYSIS PATIENTS
血液透析患者的死亡率和发病率
批准号:
2770498
负责人:
MICHAEL ALLON
金额:
$22.11万
依托单位国家:
美国
项目类别:
财政年份:
1994
资助国家:
美国
项目状态:
已结题
起止时间:
1994-09-30 至 2001-08-31

项目摘要

项目成果

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中文摘要
翻译
终末期肾病(ESRD)与显著降低的 患者存活率和严重的发病率。 40岁的人的预期寿命 年透析患者为8.8年,相比之下, 美国同年龄的人口。 回顾性研究 表明较高的Kt/V和使用具有较高通量的透析膜 更好的生物相容性可以降低 维持性血液透析患者,但很少有前瞻性研究 评估了这种操纵的效果。 这种前瞻性的、 随机、多中心研究将检验以下假设: (1)血液透析达到更高的Kt/V导致死亡率降低, 接受维持性血液透析的ESRD患者。 (2)使用高通量膜进行血液透析可降低死亡率, 发病率 (3)这两种干预措施是安全的,可被血液透析接受 患者 中心血液透析患者将随机接受透析 标准或高Kt/V治疗(1.0 vs 1.4,双池) 并且使用高通量膜或低通量膜。 科目 将被随机分配到四个实验组之一: a. Kt/V 1.40; 高通量膜 B. Kt/V 1.40; 低通量膜 C. Kt/V 1.00; 高通量膜 D. Kt/V 1.00; 低通量膜 病人的医疗和透析护理的所有其他方面将随之而来 通常的护理标准。 研究受试者将被前瞻性随访5年, 确定: a. 患者死亡率(主要终点) B. 患者发病率(次要终点) I. 非通路相关住院(尤其是心血管 事件或严重感染) 二.营养不良(血清白蛋白下降) 将分析结果以确定是否存在显着差异 四种治疗方法之间的患者生存率或发病率差异 组
英文摘要
End-stage renal disease (ESRD) is associated with a markedly reduced patient survival and substantial morbidity. The life expectancy of a 40 year-old dialysis patient is 8.8 years, as compared with 37.4 years for the general U.S. population of the same age. Retrospective studies have suggested that higher Kt/V and use of dialysis membranes with higher flux and greater biocompatibility may decrease morbidity and mortality in maintenance hemodialysis patients, but few prospective studies have evaluated the effects of such manipulations. This prospective, randomized, multicenter investigation will test the following hypotheses: (1) Hemodialysis achieving higher Kt/V results in decreased mortality in ESRD patients undergoing maintenance hemodialysis. (2) Hemodialysis with membranes of higher flux decreases mortality and morbidity. (3) These two interventions are safe and acceptable to hemodialysis patients. In-center hemodialysis patients will be randomized to receive dialysis treatments with either standard or high Kt/V (1.0 vs 1.4, double pool) and using either high flux membranes or low flux membranes. Subjects will be randomized to one of four experimental groups: a. Kt/V 1.40; High flux membrane b. Kt/V 1.40; Low flux membrane c. Kt/V 1.00; High flux membrane d. Kt/V 1.00; Low flux membrane All other aspects of the patients' medical and dialysis care will follow the usual standards of care. The study subjects will be followed prospectively for five years to determine: a. Patient mortality (primary endpoint) b. Patient morbidity (secondary endpoint) i. Non-access related hospitalization (especially cardiovascular events or serious infections) ii. Malnutrition (a decline in serum albumin) The results will be analyzed to determine whether there are significant differences in patient survival or morbidity among the four treatment groups.
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