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临床试验/NCT04088526
NCT04088526Unknown不适用

Survey and Reduction of Mortality in Uremic Patients During Peridialysis Period Via Intervention of Risk Factors

Shanghai Changzheng Hospital1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
2,500
试验地点
1
主要终点
mortality

研究概览

简要总结

In patients with non-dialysis-dependent end stage kidney disease (ESKD) the common transition of care to renal replacement therapy is dialysis. Each year over 70 000 Chinese transition from non-dialysis-dependent ESKD to dialysis. Whereas dialysis therapy is intended to be life-sustaining, ESKD patients have a 10-fold or higher risk of death compared with the general population. Mortality rates are even higher upon transition and in the first year, especially in the first 3 to 6 months following the transition to dialysis, yet it remains unknown which is the contributing cause of this high death rate. Hence, there is an urgent need to examine the emerging field of Transition of Care in ESKD. We suggest the term "peridialysis period" for this transition period for ESKD patients, so that the transition of care from non-dialysis-dependent ESKD to dialysis ESKD can be more pragmatically defined and studied. In the current study, we will investigate the mortality and its risk factors of ESKD patients during peridialysis period, and improve the survival rate and quality of life of peridialysis ESKD patients by intervening the risk factors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who have been diagnosed with end stage kidney disease (eGFR<15ml/min/1.73m2) or newly started dialysis with 3 months at all hospitals in Yangzhou, China since January 1, 2016

排除标准

  • Patients who have had a history of dialysis and have been transferred to Yangzhou during this period;
  • patients who are transferred to a dialysis area outside Yangzhou City
  • Patients who give up dialysis treatment
  • patient whose renal function recover and stop dialysis treatment;
  • Patient who receive kidney transplantation

研究组 & 干预措施

intervention group

Experimental

Through the effective intervention of risk factors for death in patients with dialysis, the effect of mortality of peri-dialysis patients was observed.

干预措施: intervention group (Combination Product)

结局指标

主要结局

mortality

时间窗: one year

mortality and death cause

次要结局

  • hospitalization(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Changlin Mei

Director of Kidney Institution of PLA

Shanghai Changzheng Hospital

研究点 (1)

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