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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01152892
Recruitment Status : Active, not recruiting
First Posted : June 29, 2010
Last Update Posted : January 26, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
End Stage Renal Disease Chronic Kidney Disease Cardiovascular Event Sudden Cardiac Death

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Stratification in End Stage Renal Disease (ISAR)
Study Start Date : April 2010
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Mortality of all causes [ Time Frame: 24 months ]
    24 month follow up

Secondary Outcome Measures :
  1. Incidence of cardiovascular events [ Time Frame: 24 months ]
    24 month follow up

  2. Blood pressure drops within a dialysis session [ Time Frame: 24 months ]
    24 month follow up

  3. Incidence of infections requiring antibiotic treatment [ Time Frame: 24 months ]
    24 month follow up

  4. Incidence of shunt thrombosis [ Time Frame: 24 months ]
    24 month follow up

  5. incidence of death and hospitalization due to infection [ Time Frame: 24 months ]
    24 month follow up

Biospecimen Retention:   Samples With DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with end stage renal disease treated with chronic hemodialysis

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
Contacts and Locations

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): NCT01152892

KFH Dialysis Center
Altötting, Bavaria, Germany, 84503
KFH Dialysis Center Dillingen
Dillingen, Bavaria, Germany, 89407
Praxen Dr. Braun Dingolfing
Dingolfing, Bavaria, Germany, 84130
KFH Dialysis Center Elsenheimerstrasse
Munich, Bavaria, Germany, 80687
KFH Dialysis Center Munich Schwabing
Munich, Bavaria, Germany, 80804
KFH Dialysis Center Munich Harlaching
Munich, Bavaria, Germany, 81545
KFH Dialysis Center Neuried
Munich, Bavaria, Germany, 82061
Dialysezentrum München Nord
München, Bavaria, Germany, 80807
Dialysezentrum München Solln
München, Bavaria, Germany, 81479
KFH Nierenzentrum Giesinger Bahnhof
München, Bavaria, Germany, 81539
Department of nephrology, Klinikum rechts der Isar
München, Bavaria, Germany, 81675
Nierenzentrum Perlach
München, Bavaria, Germany, 81737
Nierenzentrum Bogenhausen
München, Bavaria, Germany, 81925
KFH Dialysis Center Oberschleißheim
Oberschleißheim, Bavaria, Germany, 85764
KFH Dialysis Center Unterhaching
Unterhaching, Bavaria, Germany, 82008
KFH Dialysis Center Weißenburg
Weißenburg, Bavaria, Germany, 80804
Dialyse im Zentrum
München, Germany, 80337
Sponsors and Collaborators
Technische Universität München
Else Kröner Fresenius Foundation
AIT Austrian Institute of Technology GmbH
Ludwig-Maximilians - University of Munich
FH Aachen, University of applied sciences
Principal Investigator: Christoph Schmaderer, M.D., PD study chief investigator and head of the nephrological laboratory at the department of nephrology of the Klinikum rechts der Isar of the Technical University of Munich
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. Christoph Schmaderer, PD Dr. med. Christoph Schmaderer, Technische Universität München
ClinicalTrials.gov Identifier: NCT01152892     History of Changes
Other Study ID Numbers: ISAR ESRD 01 2010
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by PD Dr. Christoph Schmaderer, Technische Universität München:
end stage renal disease
chronic kidney disease
cardiovascular event
sudden cardiac death
autonomic function

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Death, Sudden, Cardiac
Urologic Diseases
Renal Insufficiency
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden