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

Renal Dialysis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06376968
• Other study ID #: BA-G-H-1604
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: B.Braun Avitum AG
• Contact: Strube Frank
• Phone: +4915257240618
• Email: frank.strube[@]bbraun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Renal Dialysis

Intervention

Device:
• BioLogic Fusion
Dialysis conducted with Dialog iQ dialysis machine either using the BioLogic Fusion option or not using it. This is only a biologic feedback system using blood pressure and residual blood volume as parameters to predict potential hypotensive episodes. If switched off, standard dialysis treatment happens, if switched on, the system tries to predict and prevent hypotensive episodes.

Locations

Country	Name	City	State
Italy	Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione	Bologna	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
B.Braun Avitum AG

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-dialysis body weight	percentage of sessions with reached prescribed post-dialysis body weight	12 weeks