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

NCT06567483 | Completed DMC

• 1 other identifier: 051466
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks

Secondary Outcomes (3)

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

  8 weeks

• Serum albumin and dialysate albumin loss

  8 weeks

• Quality of life assessment in each group

  8 weeks

Study Arms (2)

Predilution online hemodiafiltration

EXPERIMENTAL

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

Device: ELISIO21HX

Hemodialysis

ACTIVE COMPARATOR

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

Device: ELISIO21HX

Interventions

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.

Also known as: Super-high flux dialyzer

Hemodialysis; Predilution online hemodiafiltration

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hemodialysis patients in King Chulalongkorn Memorial hospital
• Residual renal function less than 100 ml/day

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Medicine Chulalongkorn university

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Rossanun Shoosanglertwijit

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

• Khajohn Tiranathanagul

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

• Pajaree Chariyavilaskul

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: August 22, 2024
• Study Start: May 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)