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

March 11, 2022 updated by: Reem Sultan, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Governorate
      • Cairo, Governorate, Egypt, 0000
        • Ain shams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Free light chain reduction
Time Frame: 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.
1 day of hemodialysis session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative albumin loss
Time Frame: 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
1 day of hemodialysis session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

February 6, 2021

First Submitted That Met QC Criteria

February 6, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD vs HDF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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