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

Risk Stratification in End Stage Renal Disease (ISAR)

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 Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Germany
  • München, Germany, 80337
    • Dialyse im Zentrum
  • Bavaria
    • Altötting, Bavaria, Germany, 84503
      • KFH Dialysis Center
    • Dillingen, Bavaria, Germany, 89407
      • KFH Dialysis Center Dillingen
    • Dingolfing, Bavaria, Germany, 84130
      • Praxen Dr. Braun Dingolfing
    • Munich, Bavaria, Germany, 80687
      • KFH Dialysis Center Elsenheimerstrasse
    • Munich, Bavaria, Germany, 80804
      • KFH Dialysis Center Munich Schwabing
    • Munich, Bavaria, Germany, 81545
      • KFH Dialysis Center Munich Harlaching
    • Munich, Bavaria, Germany, 82061
      • KFH Dialysis Center Neuried
    • München, Bavaria, Germany, 80807
      • Dialysezentrum München Nord
    • München, Bavaria, Germany, 81479
      • Dialysezentrum München Solln
    • München, Bavaria, Germany, 81539
      • KFH Nierenzentrum Giesinger Bahnhof
    • München, Bavaria, Germany, 81675
      • Department of nephrology, Klinikum rechts der Isar
    • München, Bavaria, Germany, 81737
      • Nierenzentrum Perlach
    • München, Bavaria, Germany, 81925
      • Nierenzentrum Bogenhausen
    • Oberschleißheim, Bavaria, Germany, 85764
      • KFH Dialysis Center Oberschleißheim
    • Unterhaching, Bavaria, Germany, 82008
      • KFH Dialysis Center Unterhaching
    • Weißenburg, Bavaria, Germany, 80804
      • KFH Dialysis Center Weißenburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with end stage renal disease treated with chronic hemodialysis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality of all causes	24 month follow up	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Ludwig-Maximilians - University of Munich; AIT Austrian Institute of Technology GmbH; Else Kröner Fresenius Foundation; FH Aachen, University of applied sciences
• Investigators: Principal Investigator: Christoph Schmaderer, M.D., PD, study chief investigator and head of the nephrological laboratory at the department of nephrology of the Klinikum rechts der Isar of the Technical University of Munich

Publications and helpful links

General Publications

• Bauer A, Kantelhardt JW, Barthel P, Schneider R, Makikallio T, Ulm K, Hnatkova K, Schomig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81. doi: 10.1016/S0140-6736(06)68735-7.
• Werfel S, Gunthner R, Hapfelmeier A, Hanssen H, Kotliar K, Heemann U, Schmaderer C. Identification of cardiovascular high-risk groups from dynamic retinal vessel signals using untargeted machine learning. Cardiovasc Res. 2022 Jan 29;118(2):612-621. doi: 10.1093/cvr/cvab040.
• Gunthner R, Hanssen H, Hauser C, Angermann S, Lorenz G, Kemmner S, Matschkal J, Braunisch MC, Kuechle C, Renders L, Moog P, Wassertheurer S, Baumann M, Hammes HP, Mayer CC, Haller B, Stryeck S, Madl T, Carbajo-Lozoya J, Heemann U, Kotliar K, Schmaderer C. Impaired Retinal Vessel Dilation Predicts Mortality in End-Stage Renal Disease. Circ Res. 2019 Apr 1. doi: 10.1161/CIRCRESAHA.118.314318. Online ahead of print.
• Hagmair S, Braunisch MC, Bachler M, Schmaderer C, Hasenau AL, Bauer A, Rizas KD, Wassertheurer S, Mayer CC. Implementation and verification of an enhanced algorithm for the automatic computation of RR-interval series derived from 24 h 12-lead ECGs. Physiol Meas. 2017 Jan;38(1):1-14. doi: 10.1088/1361-6579/38/1/1. Epub 2016 Dec 12.
• Schmaderer C, Tholen S, Hasenau AL, Hauser C, Suttmann Y, Wassertheurer S, Mayer CC, Bauer A, Rizas KD, Kemmner S, Kotliar K, Haller B, Mann J, Renders L, Heemann U, Baumann M. Rationale and study design of the prospective, longitudinal, observational cohort study "rISk strAtification in end-stage renal disease" (ISAR) study. BMC Nephrol. 2016 Oct 26;17(1):161. doi: 10.1186/s12882-016-0374-8.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: June 28, 2010
• First Submitted That Met QC Criteria: June 28, 2010
• First Posted (Estimate): June 29, 2010

Study Record Updates

• Last Update Posted (Estimate): January 26, 2016
• Last Update Submitted That Met QC Criteria: January 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: chronic kidney disease; autonomic function; sudden cardiac death; cardiovascular event; end stage renal disease
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Urologic Diseases; Renal Insufficiency; Death, Sudden; Heart Arrest; Kidney Diseases; Renal Insufficiency, Chronic; Death; Kidney Failure, Chronic; Death, Sudden, Cardiac
• Other Study ID Numbers: ISAR ESRD 01 2010