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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioLogic Fusion followed by standard dialysis | Experimental | Patients will be dialysed first with the BioLogic Fusion feature activated and then switched to standard dialysis with the BioLogic Fusion feature de-activated |
|
| Standard dialysis followed by BioLogic Fusion | Experimental | Patients will be dialysed first with standard dialysis with the BioLogic Fusion feature de-activated and then switched to the BioLogic Fusion feature activated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioLogic Fusion | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-dialysis body weight | percentage of sessions with reached prescribed post-dialysis body weight | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Strube Frank | Contact | +4915257240618 | frank.strube@bbraun.com | |
| Seebode Christina, Dr. | Contact | christina.seebode@bbraun.com |
| Name | Affiliation | Role |
|---|---|---|
| Annalisa Zucchelli, MD | University Hospital Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione | Recruiting | Bologna | Emilia-Romagna | 40138 | Italy |
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