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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04747067

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease Hemodiafiltration Hemodialysis	Device: BIOPURE 260HF dialyzer	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

May 1, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-flux Hemodialysis patients treated by conventional hemodialysis	Device: 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)
Experimental: Hemodiafiltration patients treated by online post-dilution hemodialysis	Device: 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)

Arm

Intervention/Treatment

Experimental: High-flux Hemodialysis

patients treated by conventional hemodialysis

Device: 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)

Experimental: Hemodiafiltration

patients treated by online post-dilution hemodialysis

Device: BIOPURE 260HF dialyzer

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospitals	Cairo	Governorate	Egypt	0000

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Reem Sultan, M.Sc, Faculty of Medicine, Ain Shams Univeristy.
Study Chair: Hesham ElSayed, PhD, Faculty of Medicine, Ain Shams Univeristy
Study Chair: Magdy ElSharkawy, PhD, Faculty of Medicine, Ain Shams Univeristy
Study Director: Waleed AbdelMohsen, PhD, Faculty of Medicine, Ain Shams Univeristy
Study Director: Shaimaa Zaki, PhD, Faculty of Medicine, Ain Shams Univeristy
Study Director: Ahmed Emara, PhD, Faculty of Medicine, Ain Shams Univeristy