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Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis
Sponsor: B.Braun Avitum AG
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2024-04-22
Completion Date
2027-06
Last Updated
2025-09-12
Healthy Volunteers
No
Conditions
Interventions
BioLogic Fusion
Dialysis 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.
Locations (1)
Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione
Bologna, Emilia-Romagna, Italy