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 University

Status: Completed

Conditions: Uremic; Toxemia

Treatments: Device: ELISIO21HX

Study type: Interventional

Funder types: Other

Identifiers

NCT06567483

051466

Details and patient eligibility

About

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.

Full 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

Enrollment: 16 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Predilution online hemodiafiltration

Experimental group

Description:

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

Treatment:

Device: ELISIO21HX

Hemodialysis

Active Comparator group

Description:

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

Treatment:

Device: ELISIO21HX