Cessation of Dialysis Treatment in Reinbek and Geesthacht (CoDiRaG)

• ClinicalTrials.gov Identifier: NCT03820765
• Recruitment Status: Recruiting
• First Posted: January 29, 2019
• Last Update Posted: January 29, 2019
• Sponsor: University of Luebeck
• Information provided by (Responsible Party): Markus Meier, MD, University of Luebeck

Study Description

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.

Condition or disease
Complication of Renal Dialysis; Long-Term Disorder of Dialysis

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with the necessity of chronic renal replacement therapy

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

Contacts and Locations

Contacts

Contact: Markus Meier, MD; ++49-40-7277860; markus.meier@dialyse-reinbek.de

Contact: Martin Nitschke, MD; ++49-451-50044121; martin.nitschke@uksh.de

Locations

Germany

Nephrology Center Reinbek and Geesthacht; Recruiting

Reinbek, Germany, 21465

Contact: Markus Meier, MD ++49-451-500-6406 markus.meier@uk-sh.de

Sub-Investigator: Markus Meier, MD

Sponsors and Collaborators

University of Luebeck

Investigators

• Principal Investigator: Markus Meier, MD; University of Luebeck

More Information

Additional Information:

Publications of Results:

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. Review.

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.

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.

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.

• Responsible Party: Markus Meier, MD, Consultant Nephrologist Dialysis and Apheresis, University of Luebeck
• ClinicalTrials.gov Identifier: NCT03820765
• Other Study ID Numbers: CODIRAG-2019
• First Posted: January 29, 2019
• Last Update Posted: January 29, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Markus Meier, MD, University of Luebeck:

Hemodialyis, Peritonealdialysis, Qualitiy assurance dialysis