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Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis

Primary Purpose

End-stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
High volume post dilution hemodiafiltration
high flux hemodialysis
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic kidney disease (CKD) stage 5 with hemodialysis or hemodiafiltration treatment for more than three months.
  • No vascular access related problems (Arteriovenous (A/V) fistula, graft or bi-flow catheter)
  • Double needle/lumen vascular access
  • No ongoing infection
  • Singed informed consent form

Exclusion Criteria:

  • Inclusion criteria not met
  • Known HIV or active hepatitis B or C infection (Positive Polymerisation Chain Reaction (PCR))
  • Pregnancy
  • Unstable clinical condition (e.g. cardiac or vascular instability)
  • Known coagulation problems
  • Patients participating in another study interfering with the planned study.

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with end-stage renal disease

Arm Description

Outcomes

Primary Outcome Measures

Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples.
Blood and dialysate samples will be analyzed for the concentration of small water soluble solutes, protein bound solutes and middle molecules. Concentrations will be used to calculate different adequacy parameters in order to compare HDF with hemodialysis (HD). Pre to post dialysis during 4h post dilution hemodiafiltration (HDF).
Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples.
Blood and dialysate samples will be analyzed for the concentration of small water soluble solutes, protein bound solutes and middle molecules. Concentrations will be used to calculate different adequacy parameters in order to compare HDF with HD. Pre to post dialysis during 8h high flux HD.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2011
Last Updated
December 13, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01445366
Brief Title
Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis
Official Title
Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
September 29, 2014 (Actual)
Study Completion Date
September 29, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective cross-over study including 10 stable hemodialysis patients with chronic kidney disease stage 5. The cross-over study lasts 2 weeks with the study dialysis sessions at midweek. During one session, the patient will be dialyzed during 4 hours with high volume post dilution hemodiafiltration (HDF) with an FX800 hemodialyzer (Fresenius Medical Care) and a blood flow of 300mL/min, dialysate flow of 500mL/min, and substitution flow of 75mL/min. During the other midweek session, the patient will be dialyzed during 8 hours with high flux hemodialysis (HD) with an FX80 hemodialyzer (Fresenius Medical Care) and a blood flow of 200mL/min and a dialysate flow of 500mL/min. The HDF and HD sessions will be randomized. Blood samples will be drawn pre and post dialysis from the arterial blood line, and after 30min after dialysis start, a blood sample will be drawn from the inlet and outlet line. At the dialysate outlet line, partial dialysate collection is performed at the outlet line. Blood and dialysate samples will be analyzed for a broad range of retention solutes like small and water soluble solutes, middle molecules, and protein bound solutes. These data will be further used to calculate solute removal and evaluate any differences between the solute removal during high volume post dilution HDF and high flux HD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with end-stage renal disease
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
High volume post dilution hemodiafiltration
Intervention Description
The midweek dialysis sessions of the patients is changed once to a 4 hours high volume post dilution hemodiafiltration (HDF) session, and once to an 8 hours high flux hemodialysis (HD) session.
Intervention Type
Device
Intervention Name(s)
high flux hemodialysis
Intervention Description
The midweek dialysis sessions of the patients is changed once to a 4 hours high volume post dilution hemodiafiltration (HDF) session, and once to an 8 hours high flux hemodialysis (HD) session.
Primary Outcome Measure Information:
Title
Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples.
Description
Blood and dialysate samples will be analyzed for the concentration of small water soluble solutes, protein bound solutes and middle molecules. Concentrations will be used to calculate different adequacy parameters in order to compare HDF with hemodialysis (HD). Pre to post dialysis during 4h post dilution hemodiafiltration (HDF).
Time Frame
During 4 hours
Title
Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples.
Description
Blood and dialysate samples will be analyzed for the concentration of small water soluble solutes, protein bound solutes and middle molecules. Concentrations will be used to calculate different adequacy parameters in order to compare HDF with HD. Pre to post dialysis during 8h high flux HD.
Time Frame
During 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic kidney disease (CKD) stage 5 with hemodialysis or hemodiafiltration treatment for more than three months. No vascular access related problems (Arteriovenous (A/V) fistula, graft or bi-flow catheter) Double needle/lumen vascular access No ongoing infection Singed informed consent form Exclusion Criteria: Inclusion criteria not met Known HIV or active hepatitis B or C infection (Positive Polymerisation Chain Reaction (PCR)) Pregnancy Unstable clinical condition (e.g. cardiac or vascular instability) Known coagulation problems Patients participating in another study interfering with the planned study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Vanholder, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

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Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis

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