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Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

End-stage Renal Disease

Treatments

Device: High volume post dilution hemodiafiltration
Device: high flux hemodialysis

Study type

Interventional

Funder types

Other

Identifiers

NCT01445366
2011/591

Details and patient eligibility

About

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.

Enrollment

13 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

13 participants in 1 patient group

Patients with end-stage renal disease
Experimental group
Treatment:
Device: High volume post dilution hemodiafiltration
Device: high flux hemodialysis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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