Green Dialysis: Dialysis With Reduced Dialysate Flow

Not Applicable

Completed

• Conditions: Uremic Syndrome
• Interventions: Other: Blood and dialysate sampling

• Registration Number: NCT05974436
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Hemodialysis patients consume per year 18.720-26.208L of dialysis fluid (i.e. water). From an ecological point of view, the present study investigated whether reducing this water amount has an impact on the extraction and total solute removal of different uremic toxins. The efficiency of hemodiafiltration with a standard high-flux dialyzer is compared to hemodialysis with a medium cut-off dialyzer with a dialysate flow of either 700mL/min or 300mL/min.

Detailed Description

Hemodialysis is currently performed with dialysate flows in the range 500 and 700mL/min respectively in hemodialysis and hemodiafiltration mode. With a standard daytime dialysis scheme of three times four hours a week, each patient consumes up to 360-504L dialysate per week or 18.720-26.208L per year.

From an ecological point of view, one can wonder whether patients can be dialyzed adequately enough using hemodialysis mode with a lower dialysate flow, and as such consuming less water.

Changing the mode from hemodiafiltration to hemodialysis mainly has an impact on the removal of larger toxins which benefit of the convective transport. Lowering dialysate flow in hemodialysis mode mainly has an impact on the removal of small water soluble toxins which are mainly removed by diffusion. For this transport, different parameters are important: blood and dialysate flow, dimensions of the membrane (surface area and thickness), fiber diameter, and extra-luminal space, and membrane porosity (Sieving coefficient). This also implies that, for the same blood and dialysate flow, the choice of the dialyzer will determine toxin transport. The use of a medium cut-off membrane with smaller and more open fibers might thus be more adequate in hemodialysis mode than a standard high-flux dialyzer with wider fibers.

The aim of this study is to quantify instant extraction and overall total solute removal of representative uremic toxins in hemodiafiltration with a standard high-flux hemodialyzer versus hemodialysis with a medium cut-off membrane, either with a standard or reduced dialysate flow.

Study Timeline

• Study Start: 2023-07-18
• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-03
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• stable chronic hemodialysis patient
• well functioning vascular access

Exclusion Criteria

• active infection
• malignancies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hemodiafiltration with high-flux dialyzer	Blood and dialysate sampling	Patients are dialysed at midweek using hemodiafiltration (autoflow) with an FX800 Cordiax high-flux dialyzer, with dialysate flow of 700mL/min
Hemodialysis with medium cut-off dialyzer and high dialysate flow	Blood and dialysate sampling	Patients are dialysed at midweek using hemodialysis with a Theranova 400 medium cut-off dialyzer with dialysate flow of 700mL/min
Hemodialysis with medium cut-off dialyzer and low dialysate flow	Blood and dialysate sampling	Patients are dialysed at midweek using hemodialysis with a Theranova 400 medium cut-off dialyzer with dialysate flow of 300mL/min

Primary Outcome Measures

Name	Time	Method
Dialysis efficiency	three midweek dialysis sessions (3 arms)	Dialyzer extraction and total solute removal are measured and calculated for different uremic toxins

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Gent, Belgium