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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-09-01

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.

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Detailed Description

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Conditions

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End Stage Renal Disease Hemodiafiltration Hemodialysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-flux Hemodialysis

patients treated by conventional hemodialysis

Group Type EXPERIMENTAL

BIOPURE 260HF dialyzer

Intervention Type DEVICE

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)

Hemodiafiltration

patients treated by online post-dilution hemodialysis

Group Type EXPERIMENTAL

BIOPURE 260HF dialyzer

Intervention Type DEVICE

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)

Interventions

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BIOPURE 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)

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Reem Sultan

Assistant lecturer of Internal Medicine and Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reem Sultan, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Ain Shams Univeristy.