Dialysis Performance of Different Dialyzer Membranes Using Different Coagulation Strategies

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ClinicalTrials.gov Identifier: NCT03820401

Recruitment Status : Completed

First Posted : January 29, 2019

Last Update Posted : January 29, 2019

Sponsor:

Collaborator:

University Ghent

Information provided by (Responsible Party):

University Hospital, Ghent

Study Description

Brief Summary:

Coagulation within the dialyzer membrane fibres is an obvious biological sign of bio-incompatibility. To avoid clotting during extracorporeal treatment, an anticoagulant is added to the circuit, resulting in an increased risk for bleeding complications.

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.

Condition or disease	Intervention/treatment	Phase
Hemodialysis Coagulation	Device: choice of dialyzer Other: choice of dialysis mode Other: choice of anticoagulation strategy Other: preparation of dialyzer	Not Applicable

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Detailed Description:

This single centre, randomized cross-over study includes ten consecutive stable chronic hemodialysis (HD) patients who experienced stable dialysis sessions during the last 4 weeks, and had no known coagulation disorder, active inflammation or malignancy.

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:

ATA™ Solacea 19H - HDF - 1/1 anticoagulation
ATA™ Solacea 19H - HDF - 1/2 anticoagulation
polysulfone FX800 - HDF - 1/1 anticoagulation
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:

ATA™ Solacea 19H - HD - 1/1 anticoagulation
ATA™ Solacea 19H - HD - 1/2 anticoagulation
polysulfone FX800 - HD - 1/1 anticoagulation
polysulfone FX800 - HD - 1/2 anticoagulation
polysulfone FX800 - HD - 1/2 anticoagulation - with predialysis albmuin priming of the membrane
Evodial - HD - no anticoagulation
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:

ATA™ Solacea 19H - pre dilution HDF (substitution 150mL/min) - 1/4 anticoagulation
ATA™ Solacea 19H - post dilution HDF (substitution 75mL/min) - 1/4 anticoagulation
ATA™ Solacea 19H - HD - 1/4 anticoagulation
ATA™ Solacea 19H - pre dilution HDF (substitution 150mL/min) - no anticoagulation
ATA™ Solacea 19H - post dilution HDF (substitution 75mL/min) - no anticoagulation
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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Quantification of Dialysis Performance of Different Dialyzer Membranes With Different Coagulation Strategies, Using a Reference microCT Scanning Technique
Actual Study Start Date :	March 7, 2018
Actual Primary Completion Date :	May 30, 2018
Actual Study Completion Date :	January 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Dietary Fiber

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies Other: preparation of dialyzer Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies Other: preparation of dialyzer Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies Other: preparation of dialyzer Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Experimental: 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	Device: choice of dialyzer Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies

Outcome Measures

Primary Outcome Measures :

Number of open fibres in the dialyzer [ Time Frame: 17 weeks ]
Number of open fibres as assessed post dialysis by a reference microCT scanning technique

Secondary Outcome Measures :

Extraction ratio of three middle molecules in the dialyzer [ Time Frame: 4 weeks ]
Extraction ratio from myoglobin, kappa and lambda free light chains as calculated from their concentrations at the dialyzer inlet en outlet

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or older
experienced stable dialysis sessions during the last 4 weeks
double needle/lumen well-functioning vascular access

Exclusion Criteria:

known coagulation disorder
active inflammation
malignancy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820401

Locations

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Belgium
Ghent University Hospital - Nephrology
Gent, Belgium

Sponsors and Collaborators

University Hospital, Ghent

University Ghent

More Information

Publications of Results:

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.

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Responsible Party:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT03820401
Other Study ID Numbers:	UGent_FiberClotting_1
First Posted:	January 29, 2019 Key Record Dates
Last Update Posted:	January 29, 2019
Last Verified:	January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Hospital, Ghent:


hemodialyzer fibre clotting

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