Cessation of Dialysis Treatment in Reinbek and Geesthacht (CoDiRaG)

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.

Study Overview

• Status: Unknown
• Conditions: Complication of Renal Dialysis; Long-Term Disorder of Dialysis

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Germany
  • Reinbek, Germany, 21465
    • Recruiting
    • Nephrology Center Reinbek and Geesthacht
    • Contact: Markus Meier, MD; Phone Number: ++49-451-500-6406; Email: markus.meier@uk-sh.de
    • Sub-Investigator: Markus Meier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with the necessity of chronic renal replacement therapy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Luebeck
• Investigators: Principal Investigator: Markus Meier, MD, University of Luebeck

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): January 31, 2020

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Hemodialyis, Peritonealdialysis, Qualitiy assurance dialysis
• Other Study ID Numbers: CODIRAG-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No