Comparing BioLogic Fusion to Standard Hemodialysis for Patients Prone to Low Blood Pressure
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
This study is testing whether a new dialysis option called BioLogic Fusion can help people who often have low blood pressure during treatment feel better and reach their target weight after dialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | B.Braun Avitum AG Industry-sponsored |
| Locations | 1 site (Bologna, Emilia-Romagna) |
| Trial ID | NCT06376968 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of the BioLogic Fusion option in patients undergoing chronic hemodialysis who are prone to hypotensive episodes. It employs a prospective, randomized, controlled, cross-over design, allowing participants to receive both treatments: one with the BioLogic Fusion activated and one without. The primary outcome is to measure the number and percentage of dialysis sessions achieving the prescribed post-dialysis body weight within the treatment time. Participants will also undergo physical examinations and complete questionnaires throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been on chronic hemodialysis for at least three months and are prone to hypotensive episodes.
Not a fit: Patients with vascular access issues or those currently participating in another interventional clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the safety and effectiveness of hemodialysis for patients who frequently experience low blood pressure.
How similar studies have performed: While this specific approach is novel, similar studies have explored various interventions in hemodialysis, but the effectiveness of BioLogic Fusion remains to be fully established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Patient on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes * No residual renal function (definition: ≤100 ml urine/day) - changed to "No to minimal residual renal function (definition: ≤ 300 ml/day)" with Amendment 1 (CIP version 6) * Stable dry body weight for at least 4 weeks * Subjects who are willing to give a voluntary consent to participate in the study Exclusion Criteria: * 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) * Pregnant or nursing women. Women of childbearing potential must agree to avoid pregnancy during the study period * Factors which may interfere with full participation in the trial * Any contra-indication to haemodialysis treatment per se, as described in the Instructions for Use (IFU) * Any serious medical condition or disability, which in the opinion of the investigator limits the life expectancy and would preclude completion of the study
Where this trial is running
Bologna, Emilia-Romagna
- Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione — Bologna, Emilia-Romagna, Italy (Recruiting)
Study contacts
- Principal investigator: Annalisa Zucchelli, MD — University Hospital Bologna
- Study coordinator: Strube Frank
- Email: frank.strube@bbraun.com
- Phone: +4915257240618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.