Clinical trial NCT03820765: Cessation of Dialysis Treatment in Reinbek and Geesthacht
Official title: Analysis of Cessation of the Dialysis Treatment in Reinbek-Northern Germany
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complication of Renal Dialysis
Long-Term Disorder of Dialysis
Keywords: Hemodialyis, Peritonealdialysis, Qualitiy assurance dialysis
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with the necessity of chronic renal replacement therapy

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* dialysis treatment period in our centers shorten than 4 weeks

Primary outcomes:
measure: Dialysis time (months) as a function of patient age (years).
timeFrame: 4 years
measure: Underlying renal disease of ESRD patients
timeFrame: 6 years
Secondary outcomes:
measure: Albumin concentration of ESRD patients
timeFrame: 6 years
Other outcomes:
Locations:
city: Reinbek
country: Germany
facility: Nephrology Center Reinbek and Geesthacht
Study officials:
affiliation: University of Luebeck
name: Markus Meier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCullough K, Sharma P, Ali T, Khan I, Smith WC, MacLeod A, Black C. Measuring the population burden of chronic kidney disease: a systematic literature review of the estimated prevalence of impaired kidney function. Nephrol Dial Transplant. 2012 May;27(5):1812-21. doi: 10.1093/ndt/gfr547. Epub 2011 Sep 29.
citation: Schober-Halstenberg HJ. End-stage renal disease in aging societies: a global perspective. J Ren Nutr. 2009 Sep;19(5 Suppl):S3-4. doi: 10.1053/j.jrn.2009.06.015. No abstract available.
citation: Frei U, Schober-Halstenberg HJ. Annual Report of the German Renal Registry 1998. QuaSi-Niere Task Group for Quality Assurance in Renal Replacement Therapy. Nephrol Dial Transplant. 1999 May;14(5):1085-90. doi: 10.1093/ndt/14.5.1085.
citation: Frei U. Quality assurance in renal replacement therapy (RRT)--background of a developing German National Registry for RRT. QuaSi-Niere Task Group. Nephrol Dial Transplant. 1995;10(4):442-3. doi: 10.1093/ndt/10.4.442. No abstract available.