Cessation of Dialysis Treatment in Reinbek and Geesthacht

NCT ID: NCT03820765

Last Updated: 2019-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2020-01-31

Brief Summary

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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

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Conditions

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Complication of Renal Dialysis Long-Term Disorder of Dialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Markus Meier, MD

Consultant Nephrologist Dialysis and Apheresis

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Meier, MD

Role: PRINCIPAL_INVESTIGATOR

University of Luebeck

Locations

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Nephrology Center Reinbek and Geesthacht

Reinbek, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Markus Meier, MD

Role: CONTACT

++49-40-7277860

Martin Nitschke, MD

Role: CONTACT

++49-451-50044121

Facility Contacts

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Markus Meier, MD

Role: primary

++49-451-500-6406

References

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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.

Reference Type RESULT
PMID: 21965592 (View on PubMed)

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.

Reference Type RESULT
PMID: 19712874 (View on PubMed)

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.

Reference Type RESULT
PMID: 10344342 (View on PubMed)

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.

Reference Type RESULT
PMID: 7623980 (View on PubMed)

Other Identifiers

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CODIRAG-2019

Identifier Type: -

Identifier Source: org_study_id

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