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

• Conditions: Cardiovascular Event; End Stage Renal Disease; Chronic Kidney Disease; Sudden Cardiac Death

• Registration Number: NCT01152892
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26
• Primary Completion: 2019-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality of all causes	24 months	24 month follow up

Secondary Outcome Measures

Name	Time	Method
Incidence of cardiovascular events	24 months	24 month follow up
Blood pressure drops within a dialysis session	24 months	24 month follow up
Incidence of infections requiring antibiotic treatment	24 months	24 month follow up
Incidence of shunt thrombosis	24 months	24 month follow up
incidence of death and hospitalization due to infection	24 months	24 month follow up

Trial Locations

Locations (17)

KFH Dialysis Center Dillingen; 🇩🇪 Dillingen, Bavaria, Germany

Praxen Dr. Braun Dingolfing; 🇩🇪 Dingolfing, Bavaria, Germany

KFH Dialysis Center; 🇩🇪 Altötting, Bavaria, Germany

KFH Dialysis Center Munich Harlaching; 🇩🇪 Munich, Bavaria, Germany

KFH Dialysis Center Neuried; 🇩🇪 Munich, Bavaria, Germany

Dialysezentrum München Nord; 🇩🇪 München, Bavaria, Germany

KFH Nierenzentrum Giesinger Bahnhof; 🇩🇪 München, Bavaria, Germany

Department of nephrology, Klinikum rechts der Isar; 🇩🇪 München, Bavaria, Germany

Nierenzentrum Perlach; 🇩🇪 München, Bavaria, Germany

Nierenzentrum Bogenhausen; 🇩🇪 München, Bavaria, Germany

KFH Dialysis Center Weißenburg; 🇩🇪 Weißenburg, Bavaria, Germany

Dialyse im Zentrum; 🇩🇪 München, Germany

KFH Dialysis Center Unterhaching; 🇩🇪 Unterhaching, Bavaria, Germany

KFH Dialysis Center Elsenheimerstrasse; 🇩🇪 Munich, Bavaria, Germany

KFH Dialysis Center Munich Schwabing; 🇩🇪 Munich, Bavaria, Germany

Dialysezentrum München Solln; 🇩🇪 München, Bavaria, Germany

KFH Dialysis Center Oberschleißheim; 🇩🇪 Oberschleißheim, Bavaria, Germany