Complication of Renal Dialysis Clinical Trial
Official title:
Analysis of Cessation of the Dialysis Treatment in Reinbek-Northern Germany
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.
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