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Cessation of Dialysis Treatment in Reinbek and Geesthacht (CoDiRaG)

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


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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820765


Contacts
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Contact: Markus Meier, MD ++49-40-7277860 markus.meier@dialyse-reinbek.de
Contact: Martin Nitschke, MD ++49-451-50044121 martin.nitschke@uksh.de

Locations
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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
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Principal Investigator: Markus Meier, MD University of Luebeck
Additional Information:

Publications of Results:
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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    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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