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NCT Number: NCT06567483

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

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.

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Key information

Conditions

Uremic; Toxemia Infections Toxemia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Chulalongkorn university

Pathum Wan, Bangkok, 10330, Thailand

About this study

Other secondary outcomes that the researcher wants to study are

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ELISIO21HX

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. Quality of life assessment in each group

    Time frame: 8 weeks

    Quality of life was assessed by the KDQOL36 questionnaire in each intervention

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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