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
Condition(s) studied
Investigational drug(s) / intervention(s)
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. Intervention duration in total 28 weeks - 12 weeks standard treatment, 4 weeks learning phase BioLogic Fusion, 12 weeks BioLogic Fusion
Study 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.
Eligibility
Primary outcome measure(s)
- Post-dialysis body weight — 12 weeks
percentage of sessions with reached prescribed post-dialysis body weight
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione | Bologna | Emilia-Romagna | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06376968 on ClinicalTrials.gov ↗ ← All trials in Italy