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Dialysis Performance of Different Dialyzer Membranes Using Different Coagulation Strategies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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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Layout table for study information
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


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




Primary Outcome Measures :
  1. 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 :
  1. 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



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.


Layout table for eligibility information
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

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
Layout table for location information
Belgium
Ghent University Hospital - Nephrology
Gent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
University Ghent
Publications of Results:
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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

Layout table for additional information
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