Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uremic; Toxemia
Keywords: Super High-flux dialyzers
Medium cut-off membrane
Protein bound uremic toxin
Indoxyl sulfate
Dialysate albumin loss
Albumin
Kappa free light chain
Lambda free light chain
Pre-dilution online HDF
Conventional hemodialysis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Protein bound uremic toxin reduction ratio (percent)
timeFrame: 8 weeks
Secondary outcomes:
measure: Beta2 microglobulin, kappa and lambda free light chain and urea reduction ratio (percent)
timeFrame: 8 weeks
measure: Serum albumin and dialysate albumin loss
timeFrame: 8 weeks
measure: Quality of life assessment in each group
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Faculty of Medicine Chulalongkorn university
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Rossanun Shoosanglertwijit
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Khajohn Tiranathanagul
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Pajaree Chariyavilaskul
role: PRINCIPAL_INVESTIGATOR
References: