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

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.

Full Title of Study: “Risk Stratification in End Stage Renal Disease (ISAR)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2019

Clinical Trial Outcome Measures

Primary Measures

  • Mortality of all causes
    • Time Frame: 24 months
    • 24 month follow up

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Technical University of Munich
  • Collaborator
    • Else Kröner Fresenius Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: PD Dr. Christoph Schmaderer, PD Dr. med. Christoph Schmaderer – Technical University of Munich
  • Overall Official(s)
    • Christoph Schmaderer, M.D., PD, Principal Investigator, 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

References

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.

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