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临床试验/NCT01152892
NCT01152892Unknown不适用

Risk Stratification in End Stage Renal Disease (ISAR)

Technical University of Munich17 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
17
主要终点
Mortality of all causes

研究概览

简要总结

The purpose of this study is to evaluate the use of non-invasive markers of the autonomic function and micro- and macrocirculation to predict mortality and cardiovascular end points in end-stage renal disease patients. Furthermore we aim at getting new insight into the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age 18 or older
  • End-stage renal disease (ESRD) and receiving maintenance hemodialysis

排除标准

  • Any clinically significant infection.
  • history of malignant disease with a prognostic life expectancy less than 24 months
  • missing of written and informed consent

结局指标

主要结局

Mortality of all causes

时间窗: 24 months

24 month follow up

次要结局

  • Incidence of cardiovascular events(24 months)
  • Blood pressure drops within a dialysis session(24 months)
  • Incidence of infections requiring antibiotic treatment(24 months)
  • Incidence of shunt thrombosis(24 months)
  • incidence of death and hospitalization due to infection(24 months)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

PD Dr. Christoph Schmaderer

PD Dr. med. Christoph Schmaderer

Technical University of Munich

研究点 (17)

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