Cessation of Dialysis Treatment in Reinbek and Geesthacht

Complication of Renal Dialysis Clinical Trial

— CoDiRaG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03820765
• Other study ID #: CODIRAG-2019
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: January 2019
• Source: University of Luebeck
• Contact: Markus Meier, MD
• Phone: ++49-40-7277860
• Email: markus.meier[@]dialyse-reinbek.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication of Renal Dialysis
• Long-Term Disorder of Dialysis

Locations

Country	Name	City	State
Germany	Nephrology Center Reinbek and Geesthacht	Reinbek

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View 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. — View 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) — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dialysis time (months) as a function of patient age (years).	Differences of the dialysis time (months) between patients < 65 years, 65-80 years and > 80 years.	4 years
Primary	Underlying renal disease of ESRD patients	Differences of the underlying renal disease between patients with initiation of dialysis prior to 31.12.2012 or after 1.1.2013	6 years
Secondary	Albumin concentration of ESRD patients	Serum albumin concentration of dialysis patients at initiation of treatment, after 6 months and at cessation of dialysis	6 years