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

Launched by B.BRAUN AVITUM AG · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option called bioLogic Fusion for patients who are on long-term dialysis and often experience low blood pressure during their sessions. The study aims to find out if using bioLogic Fusion helps patients achieve their target body weight after dialysis more effectively than standard dialysis without this option. Participants will be randomly assigned to receive treatments with and without bioLogic Fusion, and they will have regular check-ups and fill out questionnaires about their experience.

To join the study, participants must be at least 18 years old, have been on dialysis for at least three months, and experience issues with low blood pressure during treatment. They should also have a stable weight and not be enrolled in any other clinical trials. If you qualify and choose to participate, you'll help researchers understand whether this new treatment can improve the safety and effectiveness of dialysis for people like you.

Gender

ALL

Eligibility 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)
• • 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
• • 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