The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. The main question it aims to answer is:
• Which is the number and percentage of individual sessions with reached prescribed post-dialysis body weight in the prescribed treatment time in each single session in hypotensive-prone patients on high-flux haemodialysis or hemodiafiltration within each patient with treatments performed with DialogiQ with (treatment A) or without (treatment B) the bioLogic Fusion option activated? Participants will in addition to their routine dialysis treatment undergo 2 physical examinations and regularly answer questionnaires.
A crossover design is used to compare treatments with or without the BioLogic Fusion function activated.
Male or female subjects ≥18 years of age
Chronic bicarbonate standard high-flux haemodialysis or hemodiafiltration for at least 3 months
Dialysis frequency 3 x per week
Dialysis duration per session ≥ 4h
Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
Vascular access insufficiency (mean blood flow <200ml/min)
Patients treated with dialysis profiles: sodium profile, Ultrafiltration (UF) profile, and temperature profile - changed to: " Patients treated with dialysis profiles during the 9 prescreening visits: sodium profile, UF profile, and temperature profile. However, patients on sodium, ultrafiltration or temperature profiling expected to reduce intradialytic hypotensive episodes can be evaluated for enrollment when their frequency of sessions complicated by hypotension demonstrate the lack of efficacy of the applied profiles" with Amendment 1 (CIP version 6)
Use of the BioLogic fusion function during the last 9 dialysis sessions recorded at the site (retrospective screening period)
Crossover
BioLogic Fusion
DeviceDialysis conducted with Dialog iQ dialysis machine either using the BioLogic Fusion option or not using it. This is only a biologic feedback system using blood pressure and residual blood volume as parameters to predict potential hypotensive episodes. If switched off, standard dialysis treatment happens, if switched on, the system tries to predict and prevent hypotensive episodes. Intervention duration in total 28 weeks - 12 weeks standard treatment, 4 weeks learning phase BioLogic Fusion, 12 weeks BioLogic Fusion
Post-dialysis body weight
percentage of sessions with reached prescribed post-dialysis body weight
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