Green Dialysis: Dialysis With Reduced Dialysate Flow

NCT ID: NCT05974436

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-18
• Study Completion Date: 2023-09-30

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.

Conditions

Uremic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemodiafiltration with high-flux dialyzer

Patients are dialysed at midweek using hemodiafiltration (autoflow) with an FX800 Cordiax high-flux dialyzer, with dialysate flow of 700mL/min

Group Type: EXPERIMENTAL

Blood and dialysate sampling

Intervention Type: OTHER

Blood is sampled from the inlet and outlet dialyzer bloodline at 5min after dialysis start.

Spent dialysate is sampled from the outlet dialysate line at 5, 30, 90 and 240min after dialysis start.

Blood and dialysate samples are analysed for different uremic toxins. Dialysis efficiency is calculated from the analysed toxin concentrations.

Hemodialysis with medium cut-off dialyzer and high dialysate flow

Patients are dialysed at midweek using hemodialysis with a Theranova 400 medium cut-off dialyzer with dialysate flow of 700mL/min

Group Type: EXPERIMENTAL

Blood and dialysate sampling

Intervention Type: OTHER

Blood is sampled from the inlet and outlet dialyzer bloodline at 5min after dialysis start.

Spent dialysate is sampled from the outlet dialysate line at 5, 30, 90 and 240min after dialysis start.

Blood and dialysate samples are analysed for different uremic toxins. Dialysis efficiency is calculated from the analysed toxin concentrations.

Hemodialysis with medium cut-off dialyzer and low dialysate flow

Patients are dialysed at midweek using hemodialysis with a Theranova 400 medium cut-off dialyzer with dialysate flow of 300mL/min

Group Type: EXPERIMENTAL

Blood and dialysate sampling

Intervention Type: OTHER

Blood is sampled from the inlet and outlet dialyzer bloodline at 5min after dialysis start.

Spent dialysate is sampled from the outlet dialysate line at 5, 30, 90 and 240min after dialysis start.

Blood and dialysate samples are analysed for different uremic toxins. Dialysis efficiency is calculated from the analysed toxin concentrations.

Interventions

Blood and dialysate sampling

Blood is sampled from the inlet and outlet dialyzer bloodline at 5min after dialysis start.

Spent dialysate is sampled from the outlet dialysate line at 5, 30, 90 and 240min after dialysis start.

Blood and dialysate samples are analysed for different uremic toxins. Dialysis efficiency is calculated from the analysed toxin concentrations.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• stable chronic hemodialysis patient
• well functioning vascular access

Exclusion Criteria

• active infection
• malignancies

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Van Biesen, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

ONZ-2023-0170

Identifier Type: -

Identifier Source: org_study_id