MedTrace Logo

Impact of Clotting on Dialyzer Efficiency

NCT04746391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-09-19

No results posted yet for this study

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 may influence both the diffusive and convective transport characteristics of the dialyzer membrane before leading to complete dialyzer clotting. In 2018, we described a method to objectively count the number of blocked fibres inside a dialyzer using a micro-CT scanning technique. In the present trial, we use this method to assess the number of open fibers post dialysis, and this for three different dialysis durations and in two different dialyzer types. Just before the termination of the dialysis session, dialyzer clearance is assessed for different solutes from concentration measurements in blood samples as taken from the dialyzer inlet and outlet line.

The aim of this randomized cross-over study is to objectively quantify the impact of blocked fibers on the performance of different dialyzer membranes: ATA™ (asymmetric triacetate) membrane in the Solacea™ dialyzer, and polysulfone membrane in the FX800Cordiax dialyzer, and this with a decreased anticoagulation dose.

Conditions

  • Hemodialysis
  • Coagulation

Interventions

DEVICE

Dialyzer type

Fiber blocking and dialyzer clearance is calculated in two different commercially available dialyzers

OTHER

Dialysis duration

Fiber blocking and dialyzer clearance is calculated for three different dialysis durations

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Wim Van Biesen · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2021-07-01
Completion
2021-07-31

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04746391 on ClinicalTrials.gov