Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis

NCT01445366 | Completed

• 1 other identifier: 2011/591
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• 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).

  During 4 hours

• 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.

  During 8 hours

Study Arms (1)

Patients with end-stage renal disease

EXPERIMENTAL

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

Interventions

High volume post dilution hemodiafiltration DEVICE

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.

Patients with end-stage renal disease

high flux hemodialysis DEVICE

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.

Patients with end-stage renal disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raymond Vanholder, MD, 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: September 22, 2011
• First Posted: October 3, 2011
• Study Start: April 1, 2012
• Primary Completion: September 29, 2014
• Study Completion: September 29, 2014
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

BE (1)