跳至主要内容
临床试验/NCT03820401
NCT03820401已完成不适用

Quantification of Dialysis Performance of Different Dialyzer Membranes With Different Coagulation Strategies, Using a Reference microCT Scanning Technique

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年3月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Number of open fibres in the dialyzer

研究概览

简要总结

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.

详细描述

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:

  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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •known coagulation disorder
  • •active inflammation
  • •malignancy

研究组 & 干预措施

Solacea_postHDF_1/1anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

Solacea_postHDF_1/1anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

Solacea_postHDF_1/1anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

Solacea_postHDF_1/2anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

Solacea_postHDF_1/2anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

Solacea_postHDF_1/2anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

FX800_postHDF_1/1anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

FX800_postHDF_1/1anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

FX800_postHDF_1/1anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

FX800_postHDF_1/2anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

FX800_postHDF_1/2anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

FX800_postHDF_1/2anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

Solacea_HD_1/1anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

Solacea_HD_1/1anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

Solacea_HD_1/1anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

Solacea_HD_1/2anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

Solacea_HD_1/2anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

Solacea_HD_1/2anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

FX800_HD_1/1anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

FX800_HD_1/1anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

FX800_HD_1/1anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

FX800_HD_1/2anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

FX800_HD_1/2anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

FX800_HD_1/2anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

FX800_HD_1/2anticoagulation

Experimental

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

干预措施: preparation of dialyzer (Other)

FX800_HD_1/2anticoagulation_albuprime

Experimental

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

干预措施: choice of dialyzer (Device)

Solacea_preHDF_1/4anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

FX800_HD_1/2anticoagulation_albuprime

Experimental

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

干预措施: choice of dialysis mode (Other)

FX800_HD_1/2anticoagulation_albuprime

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

FX800_HD_1/2anticoagulation_albuprime

Experimental

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

干预措施: preparation of dialyzer (Other)

Evodial_HD_no anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

Evodial_HD_no anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

Evodial_HD_no anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

Evodial_HD_no anticoagulation_albuprime

Experimental

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

干预措施: choice of dialyzer (Device)

Evodial_HD_no anticoagulation_albuprime

Experimental

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

干预措施: choice of dialysis mode (Other)

Evodial_HD_no anticoagulation_albuprime

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

Evodial_HD_no anticoagulation_albuprime

Experimental

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

干预措施: preparation of dialyzer (Other)

Solacea_preHDF_1/4anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

Solacea_preHDF_1/4anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

Solacea_postHDF_1/4anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

Solacea_postHDF_1/4anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

Solacea_postHDF_1/4anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

Solacea_HD_1/4anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

Solacea_HD_1/4anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

Solacea_HD_1/4anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

Solacea_preHDF_no anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

Solacea_preHDF_no anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

Solacea_preHDF_no anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

Solacea_postHDF_no anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

Solacea_postHDF_no anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

Solacea_postHDF_no anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

Solacea_HD_no anticoagulation

Experimental

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

干预措施: choice of dialyzer (Device)

Solacea_HD_no anticoagulation

Experimental

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

干预措施: choice of dialysis mode (Other)

Solacea_HD_no anticoagulation

Experimental

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

干预措施: choice of anticoagulation strategy (Other)

结局指标

主要结局

Number of open fibres in the dialyzer

时间窗: 17 weeks

Number of open fibres as assessed post dialysis by a reference microCT scanning technique

次要结局

  • Extraction ratio of three middle molecules in the dialyzer(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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