Cessation of Dialysis Treatment in Reinbek and Geesthacht

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

• Registration Number: NCT03820765
• Lead Sponsor: University of Luebeck

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2019-01
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-25
• Last Update Submitted: 2019-01-25
• Study First Posted: 2019-01-29
• Last Update Posted: 2019-01-29
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Underlying renal disease of ESRD patients	6 years	Differences of the underlying renal disease between patients with initiation of dialysis prior to 31.12.2012 or after 1.1.2013
Dialysis time (months) as a function of patient age (years).	4 years	Differences of the dialysis time (months) between patients \< 65 years, 65-80 years and \> 80 years.

Secondary Outcome Measures

Name	Time	Method
Albumin concentration of ESRD patients	6 years	Serum albumin concentration of dialysis patients at initiation of treatment, after 6 months and at cessation of dialysis

Trial Locations

Locations (1)

Nephrology Center Reinbek and Geesthacht; 🇩🇪 Reinbek, Germany