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

Chulalongkorn University16 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uremic; Toxemia

Interventions

ELISIO21HXDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine Chulalongkorn university

Pathum Wan, Bangkok, Thailand

Outcomes

Primary Outcomes

Protein bound uremic toxin reduction ratio (percent)

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

Time frame: 8 weeks

Secondary Outcomes

Beta2 microglobulin, kappa and lambda free light chain and urea reduction ratio (percent)

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.

Time frame: 8 weeks

Serum albumin and dialysate albumin loss

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.

Time frame: 8 weeks

Quality of life assessment in each group

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

Time frame: 8 weeks

Data from ClinicalTrials.gov

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