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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Renal Dialysis
- Sponsor
- B.Braun Avitum AG
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Post-dialysis body weight
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief 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.
Investigators
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) - 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
Outcomes
Primary Outcomes
Post-dialysis body weight
Time Frame: 12 weeks
percentage of sessions with reached prescribed post-dialysis body weight