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

Risk Stratification in End Stage Renal Disease (ISAR)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01152892
Acronym
ISAR
Enrollment
500
Registered
2010-06-29
Start date
2010-04-30
Completion date
2020-05-31
Last updated
2016-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Event, Chronic Kidney Disease, End Stage Renal Disease, Sudden Cardiac Death

Keywords

end stage renal disease, chronic kidney disease, cardiovascular event, sudden cardiac death, autonomic function

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.

Interventions

None listed

Sponsors

Else Kröner Fresenius Foundation
CollaboratorOTHER
AIT Austrian Institute of Technology GmbH
CollaboratorOTHER
Ludwig-Maximilians - University of Munich
CollaboratorOTHER
FH Aachen, University of applied sciences
CollaboratorUNKNOWN
Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality of all causes24 months24 month follow up

Secondary

MeasureTime frameDescription
Incidence of cardiovascular events24 months24 month follow up
Blood pressure drops within a dialysis session24 months24 month follow up
Incidence of infections requiring antibiotic treatment24 months24 month follow up
Incidence of shunt thrombosis24 months24 month follow up
incidence of death and hospitalization due to infection24 months24 month follow up

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026