Trial record 12 of 481 for:
Open Studies | "Kidney Failure, Chronic"
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
Recruitment status was Recruiting
Sponsor:
Technische Universität München
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
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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:
- Age 18 or older
- End-stage renal disease (ESRD) and receiving maintenance hemodialysis
Exclusion Criteria:
- Any clinically significant infection.
- disturbances in electrolytes (sodium, potassium, calcium, bicarbonate) before long-term-ecg measurement
- pregnancy
- history of malignant disease with a prognostic life expectancy less than 24 months
- pace-maker device implantation, AICD implantation
- missing of written and informed consent
Contacts and Locations
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. | |
| 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. | |
| 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. | |
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:
|
Kidney Failure, Chronic Death Kidney Diseases Death, Sudden, Cardiac Renal Insufficiency, Chronic Pathologic Processes |
Urologic Diseases Renal Insufficiency Heart Arrest Heart Diseases Cardiovascular Diseases Death, Sudden |
ClinicalTrials.gov processed this record on May 16, 2013