Comparison of Efficacy in Removal of Advanced Glycation End Products (AGEs) Between Super High-flux Hemodialysis and Postdilution Online Hemodiafiltration: A Single-center, Prospective, Open-label, Crossover Randomized Controlled Trial

NCT ID: NCT05777148

Last Updated: 2023-03-21

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2023-06-30

Brief Summary

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The goal of this clinical trial is to compare efficacy in advanced glycation end products removal between Super high-flux Hemodialysis and high-volume post-dilution online hemodiafiltration. The main question it aims to answer are

* Efficacy : endothelial dysfunction biomarker (AGEs) in super high-flux hemodialysis compared to online HDF
* Safety profile : Dialysate albumin loss, Intradialytic complication

Participants will be asked to randomized in 2 groups : Super high-flux HD or post dilution ol-HDF Researchers will compare SHF-HD and ol-HDF to see whether SHF-HD could remove AGEs better than ol-HDF

Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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postdilution online hemodiafiltration

hemodialysis by using post dilution online HDF technique

Group Type EXPERIMENTAL

postdilution online hemodiafiltration

Intervention Type DEVICE

hemodialysis by post dilution online HDF technique for 24 week then crossover to super high-flux HD (wash out period 4 weeks)

super high-flux hemodialysis

hemodialysis by using super high-flux dialyzer

Group Type EXPERIMENTAL

super high-flux hemodialysis

Intervention Type DEVICE

Super high-flux hemodialysis (SHF-HD) is hemodialysis using Super high-flux dialyzer for 24 week then crossover to post dilution online HDF (wash out period 4 weeks)

Interventions

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super high-flux hemodialysis

Super high-flux hemodialysis (SHF-HD) is hemodialysis using Super high-flux dialyzer for 24 week then crossover to post dilution online HDF (wash out period 4 weeks)

Intervention Type DEVICE

postdilution online hemodiafiltration

hemodialysis by post dilution online HDF technique for 24 week then crossover to super high-flux HD (wash out period 4 weeks)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Chronic HD \> 3 months
* Adequate small molecule uremic toxins removal
* Kt/v \> 1.8 in HD 2 times/week
* Kt/v \> 1.2 in HD 3 times/week
* BFR \> 300 mL/min
* RKF \< 100 ml/day
* Hemodynamically stable for \> 2 weeks

Exclusion Criteria

* contraindicated to anticoagulant
* active malignancy
* advanced liver disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ramathibodi hospital, faculty of medicine, Ramathibodi hospital

Phaya Thai, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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3619

Identifier Type: -

Identifier Source: org_study_id

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