Clinical trial NCT01152892: Risk Stratification in End Stage Renal Disease (ESRD) - ISAR Study
Official title: Risk Stratification in End Stage Renal Disease (ISAR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Disease
Chronic Kidney Disease
Cardiovascular Event
Sudden Cardiac Death
Keywords: end stage renal disease
chronic kidney disease
cardiovascular event
sudden cardiac death
autonomic function
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Else Kröner Fresenius Foundation
name: AIT Austrian Institute of Technology GmbH
name: Ludwig-Maximilians - University of Munich
name: FH Aachen, University of applied sciences
First posted: 2010-06-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with end stage renal disease treated with chronic hemodialysis

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mortality of all causes
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of cardiovascular events
timeFrame: 24 months
measure: Blood pressure drops within a dialysis session
timeFrame: 24 months
measure: Incidence of infections requiring antibiotic treatment
timeFrame: 24 months
measure: Incidence of shunt thrombosis
timeFrame: 24 months
measure: incidence of death and hospitalization due to infection
timeFrame: 24 months
Other outcomes:
Locations:
city: Altötting
country: Germany
facility: KFH Dialysis Center
state: Bavaria
city: Dillingen
country: Germany
facility: KFH Dialysis Center Dillingen
state: Bavaria
city: Dingolfing
country: Germany
facility: Praxen Dr. Braun Dingolfing
state: Bavaria
city: Munich
country: Germany
facility: KFH Dialysis Center Elsenheimerstrasse
state: Bavaria
city: Munich
country: Germany
facility: KFH Dialysis Center Munich Schwabing
state: Bavaria
city: Munich
country: Germany
facility: KFH Dialysis Center Munich Harlaching
state: Bavaria
city: Munich
country: Germany
facility: KFH Dialysis Center Neuried
state: Bavaria
city: München
country: Germany
facility: Dialysezentrum München Nord
state: Bavaria
city: München
country: Germany
facility: Dialysezentrum München Solln
state: Bavaria
city: München
country: Germany
facility: KFH Nierenzentrum Giesinger Bahnhof
state: Bavaria
city: München
country: Germany
facility: Department of nephrology, Klinikum rechts der Isar
state: Bavaria
city: München
country: Germany
facility: Nierenzentrum Perlach
state: Bavaria
city: München
country: Germany
facility: Nierenzentrum Bogenhausen
state: Bavaria
city: Oberschleißheim
country: Germany
facility: KFH Dialysis Center Oberschleißheim
state: Bavaria
city: Unterhaching
country: Germany
facility: KFH Dialysis Center Unterhaching
state: Bavaria
city: Weißenburg
country: Germany
facility: KFH Dialysis Center Weißenburg
state: Bavaria
city: München
country: Germany
facility: Dialyse im Zentrum
Study officials:
affiliation: 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
name: Christoph Schmaderer, M.D., PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.