Efficacy and Safety of Repeated-use Middle Cut Off Membrane Dialyzers in Hemodialysis Patients
NCT06950944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2025-05-04
Summary
The goal of this clinical trial is to compare the efficacy of uremic toxin and inflammatory cytokine clearance by using reprocessing middle cutoff membrane (MCO) dialyzer in chronic hemodialysis patients. The main questions it aims to answer are:
* To evaluate efficacy of uremic toxin and inflammatory cytokine clearance and safty of hemodialysis with reprocessing MCO dialyzer compared with new MCO dialyzer
* To compare efficacy of uremic toxin and inflammatory cytokine clearance between 2 types of MCO dialyzer which availble in Thailand (Theranova 500 and Elisio 21Hx).
Participants will randomized to 2 types of MCO groups after that they will receive hemodialysis by using study dialyzer with similar hemodialysis prescription. The dialyzer in this study were reprocessing by standard hospital protocol. Researchers will compare 2 types of dialyzer groups to see efficacy of uremic toxin and inflammatory cytokine clearance and safety of use reprocessing dialyzer.
Conditions
- Hemodialysis
- Hemodialysis Treatment
- Dialysis Adequacy
Interventions
- DEVICE
-
Theranova 500
Participants will dialysis by Theranova 500 dialyzer during study period, the dialyzer will reprocessing with standard hospital protocol and dialyzer will check before use in dialysis session.
Sponsors & Collaborators
-
Khon Kaen University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-01
- Primary Completion
- 2024-03-31
- Completion
- 2024-04-30
Countries
- Thailand
Study Locations
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