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临床试验/NCT00150956
NCT00150956已完成3 期

Study Into the Effects of Daily Home Hemodialysis on Hemodynamics, Neurocognitive Functions, and Quality of Life

UMC Utrecht1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 1999年4月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
UMC Utrecht
入组人数
12
试验地点
1
主要终点
Blood pressure at 6 months

研究概览

简要总结

This study was designed to discover mechanisms responsible for the decrease in (high) blood pressure after starting daily hemodialysis, as has been observed by various investigators. We hypothesized that better control of body water and sodium content and a decline in the autonomic (sympathetic) nervous system activity, increased in chronic renal failure patients, would contribute to improved blood pressure regulation.

Moreover, we studied the effects of daily hemodialysis on mental functions, like information processing and memory, in relation to the previously reported improvement in quality of life, and the effects on nutrition. We hypothesized that all would improve.

详细描述

Although conventional hemodialysis has faced many technical improvements in recent years, a great deal of end-stage renal disease patients, treated with this modality, have suboptimal or high blood pressure, and suffer poor quality of life. Daily hemodialysis has been reported to improve both, but the pathophysiological background is poorly understood.

Patients were studied before and after 6 months of daily (i.e.6 times a week) home hemodialysis, and again after two months of conventional (i.e. thrice weekly) hemodialysis.

We measured the effects of daily dialysis (compared with conventional dialysis) on blood pressure, cardiac output, extracellular fluid volume, plasma renin activity, sympathetic nervous system activity (through MSNA), the electroencephalogram (EEG), neurocognitive functioning (speed of information processing, memory, executive functioning, and attention), quality of life, and nutritional status

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •End-stage renal disease patients
  • •Fit and motivated for home hemodialysis

排除标准

  • •Patients, who were treated with frequent dialysis (5 or 6 times a week) before
  • •Diabetes mellitus
  • •Severe comorbidity (e.g. malignancies)

结局指标

主要结局

Blood pressure at 6 months

Cardiac output at 6 months

Extracellular fluid volume at 6 months

Plasma renin activity at 6 months

Muscle sympathetic nerve activity (MSNA) at 6 months

Electroencephalogram (EEG) at 6 months

Neurocognitive functioning at 6 months

Quality of life at 6 months

次要结局

  • Nutritional status at 6 months

研究者

发起方
UMC Utrecht
申办方类型
Other

研究点 (1)

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