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

Technical University of Munich500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

KFH Dialysis Center

Altötting, Bavaria, Germany

KFH Dialysis Center Dillingen

Dillingen an der Donau, Bavaria, Germany

Outcomes

Primary Outcomes

Mortality of all causes

24 month follow up

Time frame: 24 months

Secondary Outcomes

Incidence of cardiovascular events

24 month follow up

Time frame: 24 months

Blood pressure drops within a dialysis session

24 month follow up

Time frame: 24 months

Incidence of infections requiring antibiotic treatment

24 month follow up

Time frame: 24 months

Incidence of shunt thrombosis

24 month follow up

Time frame: 24 months

incidence of death and hospitalization due to infection

24 month follow up

Time frame: 24 months

Data from ClinicalTrials.gov

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