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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Else Kröner Fresenius Foundation
AIT Austrian Institute of Technology GmbH
Ludwig-Maximilians - University of Munich
FH Aachen, University of applied sciences
Information provided by (Responsible Party):
PD Dr. Christoph Schmaderer, Technische Universität München
ClinicalTrials.gov Identifier:
NCT01152892
First received: June 28, 2010
Last updated: January 25, 2016
Last verified: January 2016
  Purpose
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
End Stage Renal Disease
Chronic Kidney Disease
Cardiovascular Event
Sudden Cardiac Death

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Stratification in End Stage Renal Disease (ISAR)

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Mortality of all causes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    24 month follow up


Secondary Outcome Measures:
  • Incidence of cardiovascular events [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    24 month follow up

  • Blood pressure drops within a dialysis session [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    24 month follow up

  • Incidence of infections requiring antibiotic treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    24 month follow up

  • Incidence of shunt thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    24 month follow up

  • incidence of death and hospitalization due to infection [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    24 month follow up


Biospecimen Retention:   Samples With DNA
Serum

Estimated Enrollment: 500
Study Start Date: April 2010
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152892

Locations
Germany
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
Investigators
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:
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 
Study First Received: June 28, 2010
Last Updated: January 25, 2016
Health Authority: Germany: Ethical comission of the faculty of medicine of the technical university munich

Keywords provided by 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
Death, Sudden, Cardiac
Urologic Diseases
Renal Insufficiency
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden

ClinicalTrials.gov processed this record on September 29, 2016