Dialysis Membranes and Hemodynamic Tolerance

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

NCT01898234

012012

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)

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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