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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Technische Universität München.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Else Kröner Fresenius Foundation
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01152892
First received: June 28, 2010
Last updated: September 17, 2010
Last verified: September 2010
  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.


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 ]

Secondary Outcome Measures:
  • Incidence of cardiovascular events [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Blood pressure drops within a dialysis session [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Incidence of infections requiring antibiotic treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Incidence of shunt thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Estimated Enrollment: 400
Study Start Date: April 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
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. disturbances in electrolytes (sodium, potassium, calcium, bicarbonate) before long-term-ecg measurement
  3. pregnancy
  4. history of malignant disease with a prognostic life expectancy less than 24 months
  5. pace-maker device implantation, AICD implantation
  6. 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
Department of nephrology, Klinikum rechts der Isar Recruiting
München, Bavaria, Germany, 81675
Contact: Christoph Schmaderer, M.D.    0049-89-4140 ext 6701    christoph.schmaderer@lrz.tum.de   
Principal Investigator: Christoph Schmaderer, M.D.         
KFH Nierenzentrum Giesinger Bahnhof Recruiting
München, Bavaria, Germany, 81539
Contact: Gabriele Schätzle, M.D.    089 1570482 ext 0    muenchen.giesingerbahnhofplatz@kfh-dialyse.de   
Principal Investigator: Gabriele Schätzle, M.D.         
Nierenzentrum Bogenhausen Recruiting
München, Bavaria, Germany, 81925
Contact: Richard Bieber, M.D.    089-45 22 ext 380    info@nierenzentrum24.de   
Principal Investigator: Richard Bieber, M.D.         
Nierenzentrum Perlach Recruiting
München, Bavaria, Germany, 81737
Contact: Carla Maceiczyk, M.D.    089 2000 ext 1820    info@nierenzentrum24.de   
Principal Investigator: Carla Maceiczyk, M.D.         
Sponsors and Collaborators
Technische Universität München
Else Kröner Fresenius Foundation
Investigators
Principal Investigator: Christoph Schmaderer, M.D. postdoc at the department of nephrology of the Klinikum rechts der Isar of the Technical University of Munich
Principal Investigator: Marcus Baumann, MD, PHD Group leader of the nephrological laboratory at the Technical University of Munich
Principal Investigator: Konstantin Kotliar, Dr. ing. Medical Engineer at the Nephrological laboratory at the Technical University of Munich
  More Information

Publications:
Responsible Party: Christoph Schmaderer, M.D., Department of nephrology, Technical university of munich
ClinicalTrials.gov Identifier: NCT01152892     History of Changes
Other Study ID Numbers: ISAR ESRD 01 2010
Study First Received: June 28, 2010
Last Updated: September 17, 2010
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:
Death, Sudden, Cardiac
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Cardiovascular Diseases
Death
Death, Sudden
Heart Arrest
Heart Diseases
Pathologic Processes
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 22, 2014