This trial is active, not recruiting.

Conditions end stage renal disease, chronic kidney disease, cardiovascular event, sudden cardiac death
Sponsor Technische Universität München
Collaborator Else Kröner Fresenius Foundation
Start date April 2010
End date May 2019
Trial size 500 participants
Trial identifier NCT01152892, ISAR ESRD 01 2010


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Mortality of all causes
time frame: 24 months

Secondary Outcomes

Incidence of cardiovascular events
time frame: 24 months
Blood pressure drops within a dialysis session
time frame: 24 months
Incidence of infections requiring antibiotic treatment
time frame: 24 months
Incidence of shunt thrombosis
time frame: 24 months
incidence of death and hospitalization due to infection
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Risk Stratification in End Stage Renal Disease (ISAR)
Principal investigator Christoph Schmaderer, M.D., PD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Technische Universität München.