Actively Recruiting
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
Led by B.Braun Avitum AG · Updated on 2025-09-12
56
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects 18 years of age or older
- On chronic bicarbonate standard high-flux haemodialysis or hemodiafiltration for at least 3 months
- Dialysis frequency of 3 times per week
- Dialysis sessions lasting 4 hours or more
- Patients prone to hypotensive episodes during chronic haemodialysis or hemodiafiltration
- No to minimal residual renal function (urine output 300 ml/day or less)
- Stable dry body weight for at least 4 weeks
- Willingness to provide voluntary consent to participate in the study
You will not qualify if you...
- Participation in another interventional clinical trial involving drugs or medical devices
- Vascular access with mean blood flow less than 200 ml/min
- Use of sodium, ultrafiltration, or temperature dialysis profiles during the 9 prescreening visits unless their use did not effectively reduce hypotensive episodes
- Use of the BioLogic Fusion function during the last 9 dialysis sessions at the study site
- Pregnant or nursing women; women of childbearing potential must agree to avoid pregnancy during the study
- Any factors interfering with full participation in the trial
- Any contraindication to haemodialysis treatment as per Instructions for Use
- Serious medical conditions or disabilities limiting life expectancy or ability to complete the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
Research Team
S
Strube Frank
CONTACT
S
Seebode Christina, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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