Dialysis Performance of the FX CorAL Membrane

NCT06203795 | Completed

• 1 other identifier: ONZ-2023-0017 PATENCY
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Anticoagulation remains an important issue in the setting of hemodialysis, and up till now there are some major points on which further research is needed. First, it is important to have a portfolio of the performance of different commercially available dialyzers with respect to fiber clotting. Second, to better estimate the impact of clotting on the overall dialysis performance, clotting kinetics during dialysis should be understood. The aim of the present project is therefore to quantify the performance of the FX CorAL dialyzer (Fresenius Medical Care, Germany) in settings with reduced anticoagulation, and compare different performance outcomes (percent open fibers, solute removal rates) to those of other commercially available dialyzers. The different outcomes are related to the dialyzer extraction ratio and reduction ratio of small and middle molecules and albumin, the visual scoring of the dialyzer post dialysis, and the anticoagulation properties as assessed by fiber blocking in the dialyzer. Performance parameters at different time steps will allow to better understand clotting kinetics during dialysis.

Conditions

Hemodialysis Complication; Anticoagulants

Keywords

dialyzer fiber clotting

Outcome Measures

Primary Outcomes (2)

• Fiber patency (i.e. number of open dialyzer fibers) in FX CorAL versus the competing dialyzers

  Patients are dialyzed with four different dialyzers: FX CorAL 800, FX 800 Cordiax, Solacea 19H and Xevonta 20Hi

  4 months

• Calculation of dialyzer extraction in FX CorAL dialyzer in the setting of reduced anticoagulation

  During the study dialysis sessions, patients only receive one quarter of their regular anticoagulation dose

  4 months

Secondary Outcomes (2)

• Time evolution of dialyzer extraction of uremic toxins and albumin

  4 months

• Time evolution of fiber patency during dialysis

  4 months

Study Arms (4)

Hemodiafiltration with FX CorAL 800 dialyzer

EXPERIMENTAL

* Patients are dialyzed three consecutive dialysis sessions with an FX CorAL 800 dialyzer, starting on Saturday. * On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday. * Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin

Other: Anticoagulation dosing; Other: Blood sampling; Other: Duration of the dialysis session; Device: Choice of the hemodialyzer

Hemodiafiltration with FX 800 Cordiax dialyzer

EXPERIMENTAL

* Patients are dialyzed three consecutive dialysis sessions with an FX 800 Cordiax dialyzer, starting on Saturday. * On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday. * Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin

Other: Anticoagulation dosing; Other: Blood sampling; Other: Duration of the dialysis session; Device: Choice of the hemodialyzer

Hemodiafiltration with Solacea 19H dialyzer

EXPERIMENTAL

* Patients are dialyzed three consecutive dialysis sessions with a Solacea 19H dialyzer, starting on Saturday. * On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday. * Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin

Other: Anticoagulation dosing; Other: Blood sampling; Other: Duration of the dialysis session; Device: Choice of the hemodialyzer

Hemodiafiltration with Xevonta Hi-20

EXPERIMENTAL

* Patients are dialyzed three consecutive dialysis sessions with a Xevonta Hi-20 dialyzer, starting on Saturday. * On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday. * Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin

Other: Anticoagulation dosing; Other: Blood sampling; Other: Duration of the dialysis session; Device: Choice of the hemodialyzer

Interventions

Anticoagulation dosing OTHER

Patients are dialyzed with only one quarter of their regular anticoagulation dose during the sessions on Tuesday and Thursday

Hemodiafiltration with FX 800 Cordiax dialyzer; Hemodiafiltration with FX CorAL 800 dialyzer; Hemodiafiltration with Solacea 19H dialyzer; Hemodiafiltration with Xevonta Hi-20

Blood sampling OTHER

Blood is sampled at start and at 10, 30, 60, 180, and 240 min after dialysis start for the 4 hours dialysis session, and at start and 10 and 180 min after dialysis start for the 3 hours dialysis session.

Hemodiafiltration with FX 800 Cordiax dialyzer; Hemodiafiltration with FX CorAL 800 dialyzer; Hemodiafiltration with Solacea 19H dialyzer; Hemodiafiltration with Xevonta Hi-20

Duration of the dialysis session OTHER

Patients have a washout with their regular dialysis duration on Saturday, a study session of 4 hours dialysis on Tuesday, and a study session of 3 hours dialysis on Thursday

Hemodiafiltration with FX 800 Cordiax dialyzer; Hemodiafiltration with FX CorAL 800 dialyzer; Hemodiafiltration with Solacea 19H dialyzer; Hemodiafiltration with Xevonta Hi-20

Choice of the hemodialyzer DEVICE

Patients are dialyzed with one of the four dialyzers during the entire week, starting at Saturday (i.a. Saturday, Tuesday and Thursday). Block randomization is performed per two weeks. In week 1 and 2, patients are dialyzed with the FX CorAL 800 and the FX 800 Cordiax. In week 3 and 4 of the study, patients are dialyzed with the Solacea 19H and the Xevonta Hi20.

Hemodiafiltration with FX 800 Cordiax dialyzer; Hemodiafiltration with FX CorAL 800 dialyzer; Hemodiafiltration with Solacea 19H dialyzer; Hemodiafiltration with Xevonta Hi-20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable chronic hemodialysis patient
• well functioning vascular access

You may not qualify if:

• known coagulation disorder
• active inflammation
• malignancy

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Wim Van Biesen, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 12, 2024
• Study Start: October 2, 2023
• Primary Completion: October 26, 2023
• Study Completion: December 1, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)