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

Not Applicable

Completed

• Conditions: End Stage Renal Disease; Hemodiafiltration; Hemodialysis
• Interventions: Device: BIOPURE 260HF dialyzer

• Registration Number: NCT04747067
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-06
• Study First Submitted QC: 2021-02-06
• Study First Posted: 2021-02-10
• Primary Completion: 2021-05-01
• Study Completion: 2021-09-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-11
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hemodiafiltration	BIOPURE 260HF dialyzer	patients treated by online post-dilution hemodialysis
High-flux Hemodialysis	BIOPURE 260HF dialyzer	patients treated by conventional hemodialysis

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Governorate, Egypt