Green Dialysis: Dialysis With Reduced Dialysate Flow

Sponsor
University Hospital, Ghent (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05974436
Collaborator
(none)
10
1
3
5.5
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood and dialysate sampling
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Green Dialysis: Hemodialysis With Reduced Dialysate Flow
Actual Study Start Date :
Jul 18, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Other: 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.

Experimental: 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

Other: 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.

Experimental: 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

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Dialysis efficiency [three midweek dialysis sessions (3 arms)]

    Dialyzer extraction and total solute removal are measured and calculated for different uremic toxins

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • stable chronic hemodialysis patient

  • well functioning vascular access

Exclusion Criteria:
  • active infection

  • malignancies

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ghent University Hospital Gent Belgium 9000

Sponsors and Collaborators

  • University Hospital, Ghent

Investigators

  • Principal Investigator: Van Biesen, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT05974436
Other Study ID Numbers:
  • ONZ-2023-0170
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Ghent
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2023