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CoDiRaG: Cessation of Dialysis Treatment in Reinbek and Geesthacht

Sponsor
University of Luebeck (Other)
Overall Status
Unknown status
CT.gov ID
NCT03820765
Collaborator
(none)
200
Enrollment
1
Location
49
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Analysis of Cessation of the Dialysis Treatment in Reinbek-Northern Germany
    Actual Study Start Date :
    Jan 1, 2016
    Anticipated Primary Completion Date :
    Dec 31, 2019
    Anticipated Study Completion Date :
    Jan 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    Secondary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Nephrology Center Reinbek and Geesthacht Reinbek Germany 21465

    Sponsors and Collaborators

    • University of Luebeck

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jan 29, 2019
    Last Update Posted:
    Jan 29, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    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, Consultant Nephrologist Dialysis and Apheresis, University of Luebeck
    Hemodialyis, Peritonealdialysis, Qualitiy assurance dialysis

    Study Results

    No Results Posted as of Jan 29, 2019