It is hypothesized that a consistent use of the Hemocontrol TM biofeedback function improves long-term cardiovascular outcome, mediated by reduced hypertension due to fluid overload and by reduced incidence of intradialytic hypotensive episodes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
396
Blood Volume Tracking system using biofeedback
Health Regional hospital
Calgary, Canada
NOT_YET_RECRUITINGHopital Tenon, APHP
Paris, France
ACTIVE_NOT_RECRUITINGAzienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
RECRUITINGCardiovascular events
The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events
Time frame: 36 months
Cardiovascular morbidity
* Number of hospital admissions evaluated as annual hospitalization rate related to: Non fatal myocardial infarction, New-onset angina, Non fatal stroke, Congestive heart failure, Transient ischemic attack, Pulmonary oedema * Length of stay during hospitalization; * Number of extra dialysis or prolonged dialysis due to fluid overload.
Time frame: 36 months
Blood pressure control
Blood pressure control: * Predialysis blood pressure measurements * Home blood pressure self assessment * Antihypertensive therapy changes * Proportion of patients achieving adequate blood pressure control * Intradialytic acute hypotension:
Time frame: 36 months
Quality of life and dialysis tolerance evaluated with questionnaire.
Questions of the KDQOL36 questionnaire
Time frame: 36 months
Dry weight management
Optional when available at site: Hydration status estimated by Cardiothoracic index or BNP or BIA at baseline and each 12 months
Time frame: 36 months
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