A Comparison of Protein-bound and Large Molecular Weight Uremic Toxin Removals With Novel Super High-flux Dialyzer Between Hemodialysis and High Volume Online HDF Modalities

August 21, 2024 updated by: Rossanun Shoosanglertwijit, MD, Chulalongkorn University

A Comparison of Protein-bound and Large Molecular Weight Uremic Toxin Removals With Novel Super High-flux Dialyzer Between Hemodialysis and High Volume Online Hemodiafiltration Modalities : A Crossover Randomized Controlled Study

The goal of this prospective, randomized, crossover study is to study about using super high-flux dialyzer in the chronic hemodialysis patients.

The main questions aim to answer are the reduction ratio of protein bound uremic toxins

Participants will undergone the pre-dilution online hemodiafiltration and conventional hemodialysis for each 8 weeks followed by washout phase for 4 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Other secondary outcomes that the researcher wants to study are

  1. The reduction ratio of Beta2microglobulin, kappa and lambda free light chain
  2. Serum albumin and dialysate albumin loss
  3. Quality of life, muscle mass and nutritional status of the patients

Study Type

Interventional

Enrollment (Actual)

16

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

  • Thailand
    • Bangkok
      • Pathum Wan, Bangkok, Thailand, 10330
        • Faculty of Medicine Chulalongkorn University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Chronic hemodialysis patients in King Chulalongkorn Memorial hospital
  • Residual renal function less than 100 ml/day

Exclusion Criteria:

  • Dialyzer allergy
  • Malnutrition requiring intradialytic parenteral nutrition
  • Cirrhosis child C or decompensated cirrhosis
  • Active uncontrolled infection
  • Active cardiovascular disease
  • Advanced stage malignancy
  • Predicted to be undergone living related kidney transplant within 1 year

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Predilution online hemodiafiltration
The dialysis mode will be set as predilution online hemodiafiltration for 8 weeks.
Device: ELISIO21HX
Super-high flux dialyzers (ELISIO21HX) will be used. The blood flow rate and dialysate flow rate will be set as 400 and 800 ml/min respectively for 4 hours of dialysis.
Other Names:
  • Super-high flux dialyzer
Active Comparator: Hemodialysis
The dialysis mode will be set as conventional hemodialysis for 8 weeks.
Device: ELISIO21HX
Super-high flux dialyzers (ELISIO21HX) will be used. The blood flow rate and dialysate flow rate will be set as 400 and 800 ml/min respectively for 4 hours of dialysis.
Other Names:
  • Super-high flux dialyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protein bound uremic toxin reduction ratio (percent)
Time Frame: 8 weeks
The reduction ratio of indoxyl sulfate will be calculated as percent by pre and post dialysis data. The measurement will take place in the pre-dialysis of the first and the last time of intervention
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beta2 microglobulin, kappa and lambda free light chain and urea reduction ratio (percent)
Time Frame: 8 weeks
The reduction ratio of the beta2 microglobulin, kappa and lambda free light chain and urea will be measure at the first and the last time of intervention by pre and post dialysis level.
8 weeks
Serum albumin and dialysate albumin loss
Time Frame: 8 weeks

Serum albumin will be followed at the midweek pre-dialysis at the first and 8th weeks of intervention.

Dialysate albumin will also be assessed at the 1st and the 8th weeks.
8 weeks
Quality of life assessment in each group
Time Frame: 8 weeks
Quality of life was assessed by the KDQOL36 questionnaire in each intervention
8 weeks

Collaborators and Investigators

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

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Rossanun Shoosanglertwijit, Chulalongkorn University
  • Principal Investigator: Khajohn Tiranathanagul, Chulalongkorn University
  • Principal Investigator: Pajaree Chariyavilaskul, Chulalongkorn University

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)

May 1, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051466

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Share only the results of the study.

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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