NCT05974436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

July 26, 2023

Last Update Submit

November 10, 2023

Conditions

Uremic Syndrome

Keywords

dialysis efficiencylowered dialysis fluid

Outcome Measures

Primary Outcomes (1)

  • Dialysis efficiency

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

    three midweek dialysis sessions (3 arms)

Study Arms (3)

Hemodiafiltration with high-flux dialyzer

EXPERIMENTAL

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

Hemodialysis with medium cut-off dialyzer and high dialysate flow

EXPERIMENTAL

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

Hemodialysis with medium cut-off dialyzer and low dialysate flow

EXPERIMENTAL

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

Interventions

Blood and dialysate samplingOTHER

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.

Hemodiafiltration with high-flux dialyzerHemodialysis with medium cut-off dialyzer and high dialysate flowHemodialysis with medium cut-off dialyzer and low dialysate flow

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable chronic hemodialysis patient
  • well functioning vascular access

You may not qualify if:

  • active infection
  • malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • 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

July 26, 2023

First Posted

August 3, 2023

Study Start

July 18, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

BE(1)