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NCT01152892 Clinical Trial

Risk Stratification in End Stage Renal Disease (ESRD) - ISAR Study

Chronic Kidney Disease Clinical Trial

— ISAR  

Official title:
Risk Stratification in End Stage Renal Disease (ISAR)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01152892
Other study ID # ISAR ESRD 01 2010
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 28, 2010
Last updated January 25, 2016
Start date April 2010
Est. completion date May 2020

Study information
Verified date January 2016
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: Ethical comission of the faculty of medicine of the technical university munich
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the use of non-invasive markers of the autonomic function and micro- and macrocirculation to predict mortality and cardiovascular end points in end-stage renal disease patients. Furthermore we aim at getting new insight into the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date May 2020
Est. primary completion date May 2019
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age 18 or older

2. End-stage renal disease (ESRD) and receiving maintenance hemodialysis

Exclusion Criteria:

1. Any clinically significant infection.

2. pregnancy

3. history of malignant disease with a prognostic life expectancy less than 24 months

4. missing of written and informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany KFH Dialysis Center Altötting Bavaria
Germany KFH Dialysis Center Dillingen Dillingen Bavaria
Germany Praxen Dr. Braun Dingolfing Dingolfing Bavaria
Germany Department of nephrology, Klinikum rechts der Isar München Bavaria
Germany Dialyse im Zentrum München
Germany Dialysezentrum München Nord München Bavaria
Germany Dialysezentrum München Solln München Bavaria
Germany KFH Nierenzentrum Giesinger Bahnhof München Bavaria
Germany Nierenzentrum Bogenhausen München Bavaria
Germany Nierenzentrum Perlach München Bavaria
Germany KFH Dialysis Center Elsenheimerstrasse Munich Bavaria
Germany KFH Dialysis Center Munich Harlaching Munich Bavaria
Germany KFH Dialysis Center Munich Schwabing Munich Bavaria
Germany KFH Dialysis Center Neuried Munich Bavaria
Germany KFH Dialysis Center Oberschleißheim Oberschleißheim Bavaria
Germany KFH Dialysis Center Unterhaching Unterhaching Bavaria
Germany KFH Dialysis Center Weißenburg Weißenburg Bavaria

Sponsors (5)
Lead Sponsor Collaborator
Technische Universität München AIT Austrian Institute of Technology GmbH, Else Kröner Fresenius Foundation, FH Aachen, University of applied sciences, Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Bauer A, Kantelhardt JW, Barthel P, Schneider R, Mäkikallio T, Ulm K, Hnatkova K, Schömig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality of all causes 24 month follow up 24 months No
Secondary Incidence of cardiovascular events 24 month follow up 24 months No
Secondary Blood pressure drops within a dialysis session 24 month follow up 24 months No
Secondary Incidence of infections requiring antibiotic treatment 24 month follow up 24 months No
Secondary Incidence of shunt thrombosis 24 month follow up 24 months No
Secondary incidence of death and hospitalization due to infection 24 month follow up 24 months No
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