Cessation of Dialysis Treatment in Reinbek and Geesthacht (CoDiRaG)
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|ClinicalTrials.gov Identifier: NCT03820765|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
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.
|Condition or disease|
|Complication of Renal Dialysis Long-Term Disorder of Dialysis|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||4 Years|
|Official Title:||Analysis of Cessation of the Dialysis Treatment in Reinbek-Northern Germany|
|Actual Study Start Date :||January 1, 2016|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||January 31, 2020|
- Dialysis time (months) as a function of patient age (years). [ Time Frame: 4 years ]Differences of the dialysis time (months) between patients < 65 years, 65-80 years and > 80 years.
- Underlying renal disease of ESRD patients [ Time Frame: 6 years ]Differences of the underlying renal disease between patients with initiation of dialysis prior to 31.12.2012 or after 1.1.2013
- Albumin concentration of ESRD patients [ Time Frame: 6 years ]Serum albumin concentration of dialysis patients at initiation of treatment, after 6 months and at cessation of dialysis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820765
|Contact: Markus Meier, MDemail@example.com|
|Contact: Martin Nitschke, MDfirstname.lastname@example.org|
|Nephrology Center Reinbek and Geesthacht||Recruiting|
|Reinbek, Germany, 21465|
|Contact: Markus Meier, MD ++49-451-500-6406 email@example.com|
|Sub-Investigator: Markus Meier, MD|
|Principal Investigator:||Markus Meier, MD||University of Luebeck|