A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser Among Patients With Chronic Haemodialysis
NCT ID: NCT04160351
Last Updated: 2022-05-19
Study Results
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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COMPLETED
NA
44 participants
INTERVENTIONAL
2019-12-01
2021-12-31
Brief Summary
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Detailed Description
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Patients who are initially on High Flux Dialyser will be randomised into either MCO Dialyser (modality A) or High Flux Dialyser (modality B) dialysate. The dialysate flow (QD) and blood flow (QB) remains unchanged throughout study period. After 12 treatments (4 weeks) a 4-weeks wash-out phase using High-flux dialyzers was performed to minimize carry-over-effects. After the 4-weeks washout phase, the modality is switched to the alternative one for 8 weeks.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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MCO Dialyser
12 treatments (4 weeks) with Medium Cut-Off Dialyzer
Theranova 400
medium cut-off dialyser
High Flux Dialyser
12 treatments (4 weeks) with High Flux Dialyzer
Elisio-19H
high flux dialyser
Interventions
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Theranova 400
medium cut-off dialyser
Elisio-19H
high flux dialyser
Eligibility Criteria
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Inclusion Criteria
2. End stage kidney failure receiving hemodialysis for at least 3 years
3. Currently receiving hemodialysis at our center regularly
4. Written informed consent
Exclusion Criteria
2. Catheter-related blood stream infection in the preceding 4 weeks
3. Malfunctioning of HD catheter
4. Planned transfer to peritoneal dialysis or transplant within 90 days
5. Pregnancy
6. History of active alcohol or substance abuse in the previous 6 months
7. Concurrent participation in another interventional study
8. Other medical condition which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
18 Years
ALL
No
Sponsors
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Selayang Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Hin Seng Wong, MD
Role: STUDY_DIRECTOR
Ministry of Health, Malaysia
Locations
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Selayang Hospital
Batu Caves, Selangor, Malaysia
Countries
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Other Identifiers
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HS/CTP/HD/001
Identifier Type: -
Identifier Source: org_study_id
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