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临床试验/NCT03820765
NCT03820765Unknown不适用

Analysis of Cessation of the Dialysis Treatment in Reinbek-Northern Germany

University of Luebeck1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Underlying renal disease of ESRD patients

研究概览

简要总结

Currently, approximately 80.000 patients with end stage renal disease (ESRD) in Germany undergo chronic renal replacement therapy, either as hemodialysis or peritonealdialysis. Since the nationwide registry for chronic dialysis patients (QuasiNiere) was terminated in 2006, no data exist from that time on regarding alterations in morbidity and mortality of patients with end stage renal disease in Germany.

With this study we start a single center prospective registry of all patients undergoing hemodialysis or peritonealdialysis therapy in our two nephrology departments Reinbek and Geesthacht. In these centers we perform approximately 34.000 hemodialysis sessions and supervise about 10.000 peritoneal treatment days of about 300 ESRD patients annually.

The aim of the study is to analyze all patients who stopped dialysis treatment in our centers due to death, kidney transplantation, recovery of renal function or other causes. Patients characteristics such as underlying renal diseases, duration of dialysis, co-morbidities as well as laboratory parameters will be recorded.

The data is collected with an Microsoft Access Database and analyzed by a statistician of the University of Luebeck (Germany). Power calculations revealed, that at least 200 patients were necessary to detect differences in particular interesting variables such as vascular access or the need of palliative care. During the last years at least 50 patients stopped chronic renal replacement therapy at out centers annually. Thus, the first interims evaluation is expected after 4 years.

The results of our study are important to estimate the development of patient age and renal diseases responsible for dialysis therapy in our centers. Moreover, the results may add important information to our internal quality assurance.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with end stage renal disease and hemodialyis or peritonealdialysis
  • Renal replacement therapy performed in our centers Reinbek or Geesthacht
  • at least 4 weeks of dialysis treatment in any of our two treatment sites

排除标准

  • dialysis treatment period in our centers shorten than 4 weeks

结局指标

主要结局

Underlying renal disease of ESRD patients

时间窗: 6 years

Differences of the underlying renal disease between patients with initiation of dialysis prior to 31.12.2012 or after 1.1.2013

Dialysis time (months) as a function of patient age (years).

时间窗: 4 years

Differences of the dialysis time (months) between patients \< 65 years, 65-80 years and \> 80 years.

次要结局

  • Albumin concentration of ESRD patients(6 years)

研究者

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

Markus Meier, MD

Consultant Nephrologist Dialysis and Apheresis

University of Luebeck

研究点 (1)

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