Cessation of Dialysis Treatment in Reinbek and Geesthacht

NCT03820765 | Unknown

• 1 other identifier: CODIRAG-2019
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Renal Dialysis; Long-Term Disorder of Dialysis

Keywords

Hemodialyis, Peritonealdialysis, Qualitiy assurance dialysis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Albumin concentration of ESRD patients

  6 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with the necessity of chronic renal replacement therapy

You may qualify if:

• 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

You may not qualify if:

• dialysis treatment period in our centers shorten than 4 weeks

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

Nephrology Center Reinbek and Geesthacht

Reinbek, 21465, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 21965592 RESULT

• 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.

  PMID: 19712874 RESULT

• 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.

  PMID: 10344342 RESULT

• 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.

  PMID: 7623980 RESULT

Study Officials

• Markus Meier, MD

  University of Luebeck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Meier, MD

CONTACT

++49-40-7277860; markus.meier@dialyse-reinbek.de

Martin Nitschke, MD

CONTACT

++49-451-50044121; martin.nitschke@uksh.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrologist Dialysis and Apheresis

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 29, 2019
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: January 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)