- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03288922
Protein-bound Toxin Removal Between Limited Blood Flow Super High-flux Online HDF and High-Efficiency Online HDF
January 23, 2018 updated by: Khajohn Tiranathanagul, Chulalongkorn University
Comparison of Protein-bound Toxins Removals Between Limited Blood Flow Online Hemodiafiltration Using Super High-flux Dialyzer and High-Efficiency Online Hemodiafiltration With High-flux Dialyzer: An Randomized Crossover Trial
High-efficiency post-dilution online hemodiafiltration (OL-HDF) using high-flux dialyzer and requiring high blood flow rate (BF ≥400 mL/min) has been reported to enhance protein-bound toxin and middle molecular toxin removal and improve patient survival.
Unfortunately, the majority of patients could not reach that high BF because of vascular access issue.
This randomized crossover study was conducted to compare these uremic toxin removals between the new modality (limited BF OL-HDF with super high-flux dialyzer) and the control (high-efficiency OL-HDF).
The OL-HDF patients were randomized to undergo either new modality or control for 2 weeks before crossover to the other modality for another 2 weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Elevated protein-bound toxins including p-cresol (pCS) and indoxyl sulfate (IDS) as well as middle-molecular toxins such as beta2-microglobulin (B2M) which could not be removed by hemodialysis (HD) are obviously correlated with high mortality.
High-efficiency post-dilution online hemodiafiltration (OL-HDF) using high-flux dialyzer and requiring high blood flow rate (BF ≥400 mL/min) has been reported to enhance pCS, IDS, and B2M removal and improve patient survival.
Unfortunately, the majority of patients could not reach that high BF because of vascular access issue.
We innovated the OL-HDF modality for this limited BF situation by integrating the novel super high-flux membrane dialyzer (SHF; PES-17Dα, Nipro Corporation, Japan) into pre-dilution OL-HDF.
This randomized crossover study was conducted to compare the uremic toxin removals between the new modality (limited BF OL-HDF with SHF) and the control (high-efficiency OL-HDF).
The OL-HDF patients were randomized to undergo either new modality or control for 2 weeks before crossover to the other modality for another 2 weeks.
Removals of pCS and IDS as well as small and middle molecule toxins were compared.
The pCS and IDS were measured by high performance liquid chromatography.
The dialysate albumin loss and patient safety were also monitored.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangkok, Thailand, 10330
- Chulalongkorn Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- End-stage renal disease patients treated with thrice-a-week OL-HDF for at least 6 months
- Residual urine < 100 mL/day
Exclusion Criteria:
- Active cardiovascular disease
- Active malignancy
- Pregnancy
- Breast-feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Limited BF OL-HDF with SHF
Limited blood flow pre-dilution online hemodiafiltration using super high-flux dialyzer which had larger pore size than standard high-flux dialyzer was assigned as the new intervention to compare the efficacy of protein-bound toxin removals with the control period.
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The new modality "Limited BF OL-HDF with SHF" were performed using Fresenius 5008 hemodiafiltration machine.
The prescribed blood flow rate was 300 ml/min and the total dialysis fluid flow rate was 800 ml/min which included pre-filter substitution rate of 150 ml/min.
The super high-flux dialyzer was PES-17Dα from Nipro Corporation, Japan which contains 1.7 m2 hollow fiber polyethersulfone membrane (ultrafiltration coefficient 80 ml/h/mmHg; urea clearance 267 ml/min, Qb 300 ml/min and Qd 500ml/min).
The patients were received this treatment thrice-a-week for 2 week before entering the wash-out period and crossover to another arm.
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Active Comparator: High-efficiency OL-HDF
High-efficiency post-dilution online hemodiafiltration using standard high-flux dialyzer was assigned as the control period.
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The controlled modality "High-efficiency OL-HDF" were performed using Fresenius 5008 hemodiafiltration machine.
The prescribed blood flow rate was 400 ml/min and the total dialysis fluid flow rate was 800 ml/min which included post-filter substitution rate of 100 ml/min.
The standard high-flux dialyzer that was used was HF80s from Fresenius Medical Care, Germany contains 1.8 m2 hollow fiber polysulfone membrane (ultrafiltration coefficient 55 ml/h/mmHg; urea clearance 248 ml/min, Qb 300ml/min and Qd 500 ml/min).
The patients were received this treatment thrice-a-week for 2 week before entering the wash-out period and crossover to another arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pCS percentage of reduction ratio
Time Frame: At time 0-hour and 4-hour of the study online hemodiafiltration session
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Blood samples were taken from patients before and at the end of 4-hour in the first dialysis session of each modality.
pCS levels were measured by high-performance liquid chromatography (HPLC).
The percentage of reduction ratio were calculated from the before and ending samples.
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At time 0-hour and 4-hour of the study online hemodiafiltration session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IDS percentage of reduction ratio
Time Frame: At time 0-hour and 4-hour of the study online hemodiafiltration session
|
Blood samples were taken from patients before and at the end of 4-hour in the first session of each modality.
IDS levels were measured by high-performance liquid chromatography (HPLC).
The percentage of reduction ratio were calculated from the before and ending samples.
|
At time 0-hour and 4-hour of the study online hemodiafiltration session
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Beta2-microglobulin percentage of reduction ratio
Time Frame: At time 0-hour and 4-hour of the study online hemodiafiltration session
|
Blood samples were taken from patients before and at the end of 4-hour in the first dialysis session of each modality.
The percentage of reduction ratio were calculated from the before and ending samples.
|
At time 0-hour and 4-hour of the study online hemodiafiltration session
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Albumin loss in spent dialysate
Time Frame: During 4 hours of online hemodiafiltration session
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Continuous sampling of spent effluent dialysate and ultrafiltrate were carried out with a collection pump inserted into the effluent outlet line via a special connector for total albumin loss determination.
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During 4 hours of online hemodiafiltration session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wanjak Pongsittisak, Chulalongkorn University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
September 18, 2017
First Submitted That Met QC Criteria
September 18, 2017
First Posted (Actual)
September 20, 2017
Study Record Updates
Last Update Posted (Actual)
January 25, 2018
Last Update Submitted That Met QC Criteria
January 23, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 291/58
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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