Expanded Hemodialysis Versus High-Volume Online Hemodiafiltration for Uremic Toxin Removal
NCT ID: NCT07348536
Last Updated: 2026-01-16
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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RECRUITING
NA
15 participants
INTERVENTIONAL
2025-08-10
2026-01-20
Brief Summary
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Two dialysis techniques are commonly used to improve toxin removal beyond standard hemodialysis: expanded hemodialysis (HDx) using medium cut-off membranes, and high-volume online hemodiafiltration (HV-OL-HDF). Although both techniques are effective, the best way to prescribe expanded hemodialysis-particularly the ideal treatment time-has not been clearly defined.
The purpose of this study is to compare how well different treatment times of expanded hemodialysis remove small and medium-sized uremic toxins, and to compare these results with high-volume online hemodiafiltration. Toxin removal will be evaluated using a combined measurement called the Global Removal Score, which summarizes the removal of several important waste substances.
This is a single-center, randomized, open-label, crossover study. Adults receiving maintenance hemodialysis will receive three different expanded hemodialysis sessions with different treatment durations (180, 210, and 240 minutes), followed by one session of high-volume online hemodiafiltration. Blood samples will be taken before and after each dialysis session to measure toxin levels.
The results of this study may help determine whether expanded hemodialysis with shorter or standard treatment times can achieve toxin removal similar to high-volume hemodiafiltration, which could support more personalized and practical dialysis prescriptions.
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Detailed Description
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While expanded hemodialysis has shown removal efficiency comparable to high-volume hemodiafiltration in prior studies, the optimal prescription of HDx-particularly the appropriate treatment duration-has not been clearly established. In routine clinical practice, dialysis dose is commonly guided by small-solute clearance (such as urea), which may not fully reflect the removal of medium-sized uremic toxins. A more comprehensive evaluation of toxin removal may help optimize dialysis prescriptions and improve treatment personalization.
This study is designed to compare the efficiency of uremic toxin removal across different expanded hemodialysis treatment durations and to contrast these results with high-volume online hemodiafiltration. Removal efficiency will be assessed using the Global Removal Score, a composite measure that integrates the removal rates of several small and medium-sized molecules while accounting for albumin loss.
The study is a single-center, randomized, open-label, crossover trial conducted in adult patients receiving maintenance hemodialysis. Each participant will receive three expanded hemodialysis sessions with different treatment durations (180, 210, and 240 minutes), administered in randomized sequences following the long interdialytic interval. After completion of the three expanded hemodialysis sessions, all participants will undergo one session of high-volume online hemodiafiltration with a predefined convective volume target.
During each study session, blood samples will be collected immediately before and after dialysis to measure concentrations of selected uremic toxins, including small solutes and medium-sized molecules. These measurements will be used to calculate individual and global removal rates for each dialysis modality and treatment duration. Standard dialysis parameters will be maintained according to institutional practice to ensure patient safety and consistency across sessions.
The crossover design allows each participant to serve as their own control, reducing variability related to patient-specific factors. The primary analysis will compare global toxin removal between expanded hemodialysis prescriptions and high-volume online hemodiafiltration, as well as across different HDx treatment durations.
The findings of this study may help clarify whether expanded hemodialysis with shorter or standard treatment times can achieve toxin removal comparable to high-volume hemodiafiltration. This information could support more individualized dialysis prescriptions and inform clinical decision-making in settings where high-volume hemodiafiltration is not feasible or routinely available.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Expanded Hemodialysis Prescriptions and High-Volume Online Hemodiafiltration
Participants will receive three expanded hemodialysis sessions with different treatment durations (180, 210, and 240 minutes) in randomized order, followed by one session of high-volume online hemodiafiltration. Blood samples will be collected before and after each session to assess uremic toxin removal.
Expanded Hemodialysis With Medium Cut-Off Membrane
Expanded hemodialysis will be performed using a medium cut-off dialysis membrane designed to enhance the removal of medium-sized uremic toxins while preserving albumin. Treatments will be delivered during regularly scheduled dialysis sessions with fixed dialysate flow and the maximum blood flow tolerated by the participant. Each participant will receive expanded hemodialysis sessions with three different treatment durations (180, 210, and 240 minutes), administered in randomized order following the long interdialytic interval. Blood samples will be collected before and after each session to assess removal of small and medium-sized uremic toxins.
High-Volume Online Hemodiafiltration
High-volume online hemodiafiltration will be delivered using post-dilution substitution during a standard dialysis session. Treatment will target a predefined convective volume consistent with high-volume hemodiafiltration while maintaining standard dialysis safety parameters. This intervention will be administered once to each participant after completion of the expanded hemodialysis sessions. Blood samples will be collected before and after the session to measure removal of small and medium-sized uremic toxins for comparison with expanded hemodialysis.
Interventions
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Expanded Hemodialysis With Medium Cut-Off Membrane
Expanded hemodialysis will be performed using a medium cut-off dialysis membrane designed to enhance the removal of medium-sized uremic toxins while preserving albumin. Treatments will be delivered during regularly scheduled dialysis sessions with fixed dialysate flow and the maximum blood flow tolerated by the participant. Each participant will receive expanded hemodialysis sessions with three different treatment durations (180, 210, and 240 minutes), administered in randomized order following the long interdialytic interval. Blood samples will be collected before and after each session to assess removal of small and medium-sized uremic toxins.
High-Volume Online Hemodiafiltration
High-volume online hemodiafiltration will be delivered using post-dilution substitution during a standard dialysis session. Treatment will target a predefined convective volume consistent with high-volume hemodiafiltration while maintaining standard dialysis safety parameters. This intervention will be administered once to each participant after completion of the expanded hemodialysis sessions. Blood samples will be collected before and after the session to measure removal of small and medium-sized uremic toxins for comparison with expanded hemodialysis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* End stage renal disease Receiving maintenance hemodialysis three times per week on expanded hemodialysis as part of routine care for at least 1 month
* On dialysis treatment for more than 3 months
* Minimal or no residual urine output (less than 100 mL per day)
* Able and willing to provide written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Responsible Party
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Olynka Vega
Principal investigator
Principal Investigators
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Olynka Vega, MS
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Locations
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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
Mexico City, Mexico City, Mexico
Countries
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Central Contacts
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Other Identifiers
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NMM-4853
Identifier Type: -
Identifier Source: org_study_id
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