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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-03-01

Brief Summary

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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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Detailed Description

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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

Conditions

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Uremic; Toxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

After a run-in period, the patients were randomly allocated to receive either 8-week of predilution hemodiafiltration using super-high flux, ELISIO-21HX, or hemodialysis using super-high flux as the control treatment. After a wash-out period of hemodiafiltration using high flux dialyzer, they were assigned to receive the other treatment for 8 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Predilution online hemodiafiltration

The dialysis mode will be set as predilution online hemodiafiltration for 8 weeks.

Group Type EXPERIMENTAL

ELISIO21HX

Intervention Type 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.

Hemodialysis

The dialysis mode will be set as conventional hemodialysis for 8 weeks.

Group Type ACTIVE_COMPARATOR

ELISIO21HX

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Super-high flux dialyzer

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes