To Assess the Effect of HDF Versus High Flux Dialysis on Free Light Chains and Cumulative Albumin Loss, in End Stage Renal Disease Patients.

Study Overview
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Brief Summary
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Removal of uremic toxins is the main goal of HD, It was improved by using high volume convective technique with high flux (HF) dialyzer. This technique removes medium - large molecular weight solutes giving higher dialysis adequacy and consequently improving the quality of life. This study will assess the effect of hemodiafiltration (HDF) versus high flux dialysis on free light chains (FLC) reduction as a marker of HD adequacy and its relation to albumin loss using dialyzer effective surface area 2.6m2.

Official Title
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The Effect of Hemodiafiltration Versus High Flux Dialysis On Free Light Chains Reduction And Its Relation To Albumin Loss.

Conditions
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End Stage Renal Disease, Hemodiafiltration, Hemodialysis

Intervention / Treatment
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* Device: BIOPURE 260HF dialyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prevalent HD patients on regular hemodialysis sessions for >6 months 3 sessions/week of 4 hours duration. Patients with Arterio-venous fistula as dialysis access. Exclusion Criteria: Patients with hemodialysis catheters. Patients with active inflammation or infection. Decompensated heart failure. Liver Cell Failure ( Child B,C) Patients with known malignancies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: It is a pilot crossover study, 25 ESRD patients were dialyzed using dialyzer; BIOPURE 260 HF on a single session on two hemodialysis modalities (conventional HD and online post-dilution HDF) with washout period of 2 weeks using high flux dialyzers with maximum surface area 2.0 m2.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-flux Hemodialysis<br>patients treated by conventional hemodialysis | Device: BIOPURE 260HF dialyzer<br>* Dialyzer with effective surface area 2.6 m2, High-flux polyethersulfone hollow fiber with steam sterilization, myoglobin sieving coefficient (SC) 0.7, membrane cutoff 40,000 Daltons (Allmed Medical Gmbh)<br>|
| Experimental: Hemodiafiltration<br>patients treated by online post-dilution hemodialysis | Device: BIOPURE 260HF dialyzer<br>* Dialyzer with effective surface area 2.6 m2, High-flux polyethersulfone hollow fiber with steam sterilization, myoglobin sieving coefficient (SC) 0.7, membrane cutoff 40,000 Daltons (Allmed Medical Gmbh)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free light chain reduction | Measurement of kappa (23KDa) and lambda (45 KDa)free light chains levels, pre and post dialysis session, in patients undergoing high-flux dialysis versus HDF. | 1 day of hemodialysis session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative albumin loss | Assessment of cumulative dialysate albumin loss by measuring albumin spent in dialysate -hourly- in patients undergoing high flux dialysis versus HDF | 1 day of hemodialysis session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End stage renal disease (ESRD), hemodiafiltration (HDF), hemodialysis (HD), Free light chains, Albumin loss, Kappa and lambda