Green Dialysis: Dialysis With Reduced Dialysate Flow

November 10, 2023 updated by: University Hospital, Ghent

Green Dialysis: Hemodialysis With Reduced Dialysate Flow

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • stable chronic hemodialysis patient
  • well functioning vascular access

Exclusion Criteria:

  • active infection
  • malignancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dialysis efficiency
Time Frame: three midweek dialysis sessions (3 arms)
Dialyzer extraction and total solute removal are measured and calculated for different uremic toxins
three midweek dialysis sessions (3 arms)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2023-0170

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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