Dialysis Performance of Different Dialyzer Membranes Using Different Coagulation Strategies
NCT ID: NCT03820401
Last Updated: 2019-01-29
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
20 participants
INTERVENTIONAL
2018-03-07
2019-01-17
Brief Summary
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In addition, there is evidence that a substantial number of fibers can become blocked before this is reflected in routinely observed parameters, or in termination of the dialysis session. Little is known about the impact of such subclinical clotting on dialyzer performance in terms of solute clearance.
Membrane clogging due to deposition of proteins and red blood cells on the dialysis membrane may influence both the diffusive and convective transport characteristics of the dialyzer membrane before leading to complete dialyzer clotting.
In 2018, the invesitgators described a method to objectively count the number of blocked fibres inside a dialyzer using a micro-CT scanning technique.
In the present trial, the investigators use this method to assess the resistance of the dialyzer to clotting, and to evaluate the impact of subclinical fibre blocking on solute removal and thus performance of a dialyzer during a dialysis session.
The aim of this randomized cross-over study is to objectively quantify the performance of different dialyzer membranes: ATA™ membrane in the Solacea™ dialyzer, polysulfone membrane in the FX800 dialyzer, and the heparin-coated AN membrane in the Evodial dialyzer, and this with different anticoagulation strategies.
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Detailed Description
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Double-needle vascular access is achieved through a native arterio-venous fistula or a well-functioning double lumen tunnelled central venous catheter.
In a first test series, each patient is dialyzed for 240min (at midweek) in 4 different regimens, randomly using 2 different dialyzers and 2 different anticoagulation schemes. Patients receive their regular brand of Low-Molecular-Weight Heparin anticoagulation at the beginning of the dialysis session, and this randomly either at their regular dose (full dose 1/1) or at only 50% of their regular dose (half dose 1/2). All test sessions are performed with blood flow at 300mL/min and dialysate flow at 500mL/min in post dilution hemodiafiltration (HDF) mode (substitution flow 75mL/min). Ultrafiltration rates is set according to the patient's interdialytic weight gain and clinical status:
1. ATA™ Solacea 19H - HDF - 1/1 anticoagulation
2. ATA™ Solacea 19H - HDF - 1/2 anticoagulation
3. polysulfone FX800 - HDF - 1/1 anticoagulation
4. polysulfone FX800 - HDF - 1/2 anticoagulation
During the 4 experimental midweek sessions, blood is sampled from the arterial and venous blood lines, and spent dialysate is sampled from the outlet line, all at 60min after the dialysis start. Blood samples are immediately centrifuged and serum and dialysate are stored at -80°C until batch analysis.
Concentrations of urea, kappa and lambda free light chains, and myoglobin are determined. Extraction ratios and adsorption on the membrane are calculated from concentrations.
At the end of the dialysis session, a standard rinsing procedure of the hemodialyzer is performed using exact 300mL rinsing solution. Next, the hemodialyzer is dried using continuous positive pressure ventilation. Dialyzer fibre blocking is visualized in the dialyzer outlet potting using a 3D CT scanning technique on micrometer resolution. HECTOR is a High Energy CT scanner Optimized for Research, built by the Ghent University Centre for X-ray Tomography (UGCT) in collaboration with the UGCT spin-off company XRE (Gent, Belgium). In front of the X-ray source, the dialyzer is mounted vertically on a precision rotation stage, and radiographies were recorded over 360° with an angular interval of 0.15°. Scan conditions are optimized to maximize the signal-to-noise ratio based on the sample size and structure, and the scanner properties. The tube voltage is set at 80kV, at a power of 20 Watts, the maximal power that allowed imaging at a resolution of 25µm. A total of 2401 projections are recorded with 500ms exposure each, resulting in a total exposure time of 20 minutes. Acquired images at 0 (projection 1) and 360° (projection 2401) are compared to exclude movement of the hemodialyzer during the scanning process. Reconstruction of the raw projection data is performed with the Octopus Reconstruction software package, licensed by XRE23.
Fibers are counted in the central cross-section of the dialyzer outlet potting in a computer-based way using the Fiji image processing toolkit of ImageJ analysis software (ImageJ 1.51H, NIH, Bethesda, USA), an open-source platform for biological-image analysis.
In a second test series in 10 stable HD patients, no blood sampling is performed but dialyzers are scanned post dialysis. The following different dialyzers in HD modus at midweek are tested:
1. ATA™ Solacea 19H - HD - 1/1 anticoagulation
2. ATA™ Solacea 19H - HD - 1/2 anticoagulation
3. polysulfone FX800 - HD - 1/1 anticoagulation
4. polysulfone FX800 - HD - 1/2 anticoagulation
5. polysulfone FX800 - HD - 1/2 anticoagulation - with predialysis albmuin priming of the membrane
6. Evodial - HD - no anticoagulation
7. Evodial - HD - no anticoagulation - with predialysis albmuin priming of the membrane
In a third test series in 10 stable HD patients, no blood sampling is performed but dialyzers are scanned post dialysis. The following different dialyzers at midweek are tested:
1. ATA™ Solacea 19H - pre dilution HDF (substitution 150mL/min) - 1/4 anticoagulation
2. ATA™ Solacea 19H - post dilution HDF (substitution 75mL/min) - 1/4 anticoagulation
3. ATA™ Solacea 19H - HD - 1/4 anticoagulation
4. ATA™ Solacea 19H - pre dilution HDF (substitution 150mL/min) - no anticoagulation
5. ATA™ Solacea 19H - post dilution HDF (substitution 75mL/min) - no anticoagulation
6. ATA™ Solacea 19H - HD - no anticoagulation
First outcome measure: relative number of open fibers in each tested dialyzer. Second outcome measure: dialyzer performance (extraction ratio, adsorption).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Solacea_postHDF_1/1anticoagulation
intervention:
* choice of dialyzer: Solacea dialyzer (Nipro, Japan)
* choice of dialysis mode: post dilution hemodiafiltration
* choice of anticoagulation strategy: standard anticoagulation dose
measurements:
* blood \& dialysate sampling at 60min after dialysis start
* microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Solacea_postHDF_1/2anticoagulation
intervention:
* choice of dialyzer: Solacea dialyzer (Nipro Japan)
* choice of dialysis mode: post dilution hemodiafiltration
* choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose
measurements:
* blood \& dialysate sampling at 60min after dialysis start
* microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
FX800_postHDF_1/1anticoagulation
intervention:
* choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)
* choice of dialysis mode: post dilution hemodiafiltration
* choice of anticoagulation strategy: standard anticoagulation dose
measurements:
* blood \& dialysate sampling at 60min after dialysis start
* microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
FX800_postHDF_1/2anticoagulation
intervention:
* choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)
* choice of dialysis mode: post dilution hemodiafiltration
* choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose
measurements:
* blood \& dialysate sampling at 60min after dialysis start
* microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Solacea_HD_1/1anticoagulation
intervention:
* choice of dialyzer: Solacea dialyzer (Nipro, Japan)
* choice of dialysis mode: hemodialysis
* choice of anticoagulation strategy: standard anticoagulation dose
measurement:
\- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Solacea_HD_1/2anticoagulation
intervention:
* choice of dialyzer: Solacea dialyzer (Nipro, Japan)
* choice of dialysis mode: hemodialysis
* choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose
measurements:
\- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
FX800_HD_1/1anticoagulation
intervention:
* choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)
* choice of dialysis mode: hemodialysis
* choice of anticoagulation strategy: standard anticoagulation dose
measurements:
\- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
FX800_HD_1/2anticoagulation
intervention:
* choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)
* choice of dialysis mode: hemodialysis
* choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose
measurements:
\- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
preparation of dialyzer
Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not
FX800_HD_1/2anticoagulation_albuprime
intervention:
* choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)
* choice of dialysis mode: hemodialysis
* choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose
* preparation of dialyzer: the dialyzer was preprimed with albumin solution
measurement:
\- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
preparation of dialyzer
Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not
Evodial_HD_no anticoagulation
intervention:
* choice of dialyzer: Evodial 1.3 (Baxter, USA)
* choice of dialysis mode: hemodialysis
* choice of anticoagulation strategy: no anticoagulation is administered
measurement:
\- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Evodial_HD_no anticoagulation_albuprime
intervention:
* choice of dialyzer: Evodial 1.3 (Baxter, USA)
* choice of dialysis mode: hemodialysis
* choice of anticoagulation strategy: no anticoagulation is administered
* preparation of dialyzer: the dialyzer was preprimed with albumin solution
measurement:
\- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
preparation of dialyzer
Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not
Solacea_preHDF_1/4anticoagulation
intervention:
* choice of dialyzer: Solacea dialyzer (Nipro Japan)
* choice of dialysis mode: pre dilution hemodiafiltration
* choice of anticoagulation strategy: the patient receives only 1/4th of his/her standard anticoagulation dose
measurements:
\- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Solacea_postHDF_1/4anticoagulation
intervention:
* choice of dialyzer: Solacea dialyzer (Nipro Japan)
* choice of dialysis mode: post dilution hemodiafiltration
* choice of anticoagulation strategy: the patient receives only 1/4th of his/her standard anticoagulation dose
measurements:
\- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Solacea_HD_1/4anticoagulation
intervention:
* choice of dialyzer: Solacea dialyzer (Nipro Japan)
* choice of dialysis mode: hemodialysis
* choice of anticoagulation strategy: the patient receives only 1/4th of his/her standard anticoagulation dose
measurements:microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Solacea_preHDF_no anticoagulation
intervention:
* choice of dialyzer: Solacea dialyzer (Nipro Japan)
* choice of dialysis mode: pre dilution hemodiafiltration
* choice of anticoagulation strategy: no anticoagulation is administered
measurements:
\- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Solacea_postHDF_no anticoagulation
intervention:
* choice of dialyzer: Solacea dialyzer (Nipro Japan)
* choice of dialysis mode: post dilution hemodiafiltration
* choice of anticoagulation strategy: no anticoagulation is administered
measurements:
\- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Solacea_HD_no anticoagulation
intervention:
* choice of dialyzer: Solacea dialyzer (Nipro Japan)
* choice of dialysis mode: hemodialysis
* choice of anticoagulation strategy: no anticoagulation is administered
measurements:
\- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Interventions
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choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers
choice of dialysis mode
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
choice of anticoagulation strategy
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
preparation of dialyzer
Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not
Eligibility Criteria
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Inclusion Criteria
* experienced stable dialysis sessions during the last 4 weeks
* double needle/lumen well-functioning vascular access
Exclusion Criteria
* active inflammation
* malignancy
18 Years
ALL
No
Sponsors
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University Ghent
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Locations
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Ghent University Hospital - Nephrology
Ghent, , Belgium
Countries
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References
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Vanommeslaeghe F, Van Biesen W, Dierick M, Boone M, Dhondt A, Eloot S. Micro-computed tomography for the quantification of blocked fibers in hemodialyzers. Sci Rep. 2018 Feb 8;8(1):2677. doi: 10.1038/s41598-018-20898-w.
Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
Other Identifiers
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UGent_FiberClotting_1
Identifier Type: -
Identifier Source: org_study_id
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