End Stage Renal Disease, Hemodiafiltration, Hemodialysis
Conditions
Keywords
End stage renal disease (ESRD), hemodiafiltration (HDF), hemodialysis (HD), Free light chains, Albumin loss, Kappa and lambda
Brief summary
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.
Interventions
DEVICEBIOPURE 260HF dialyzer
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)
Sponsors
Ain Shams University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Free light chain reduction | 1 day of hemodialysis session | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative albumin loss | 1 day of hemodialysis session | Assessment of cumulative dialysate albumin loss by measuring albumin spent in dialysate -hourly- in patients undergoing high flux dialysis versus HDF |
Countries
Egypt
Outcome results
None listed