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Dialysis Membranes and Hemodynamic Tolerance

O

Ospedale Regionale di Locarno

Status

Completed

Conditions

Dialysis Membranes and Hemodynamic Tolerance

Treatments

Device: Helixone low flux
Device: Revaclear
Device: Helixone high flux
Device: Xevonta

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Background:

High- and low-flux dialysis membranes made of different materials may correlate with various hemodynamic tolerance profiles. This study aims to investigate hemodynamic response and incidence of hypotensive episodes by comparing some of the most commonly used high- and low-flux dialyzers.

Methodology:

The study was designed as an open label, randomized, cross-over investigation, including 25 patients undergoing chronic hemodialysis. Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other. The hemodynamic profile was assessed with a non-invasive technique and patients were asked to provide tolerance feedback through a questionnaire.

Enrollment

25 patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age 18 and older
  • ability to understand the information presented and sign the informed consent
  • chronic hemodialysis for at least 8 weeks
  • stable dialysis prescriptions and modality in the 2 weeks prior to protocol implementation

Exclusion criteria

  • mental illness;
  • inability to understand the information presented and sign the informed consent;
  • acute disease requiring hospitalization at the time of patient enrolment
  • pregnancy and breast feeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

25 participants in 4 patient groups

Revaclear
Experimental group
Treatment:
Device: Revaclear
Helixone high flux
Experimental group
Treatment:
Device: Helixone high flux
Xevonta
Experimental group
Treatment:
Device: Xevonta
Helixone low flux
Experimental group
Treatment:
Device: Helixone low flux

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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