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

Phase

N/A

Condition

Circulation Disorders

Hemodialysis

Vascular Diseases

Treatment

BioLogic Fusion

Clinical Study ID

NCT06376968

BA-G-H-1604

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Male or female subjects ≥18 years of age
Chronic bicarbonate standard high-flux haemodialysis or hemodiafiltration for atleast 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 tominimal residual renal function (definition: ≤ 300 ml/day)" with Amendment 1 (CIPversion 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

Exclusion Criteria:

Simultaneous participation in another interventional clinical trial (drugs ormedical 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 dialysisprofiles during the 9 prescreening visits: sodium profile, UF profile, andtemperature profile. However, patients on sodium, ultrafiltration or temperatureprofiling expected to reduce intradialytic hypotensive episodes can be evaluated forenrollment when their frequency of sessions complicated by hypotension demonstratethe 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 atthe site (retrospective screening period)
Pregnant or nursing women. Women of childbearing potential must agree to avoidpregnancy 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 theInstructions for Use (IFU)
Any serious medical condition or disability, which in the opinion of theinvestigator limits the life expectancy and would preclude completion of the study

Study Design