NCT01898234

Dialysis Membranes and Hemodynamic Tolerance

Assessment of Subjective and Hemodynamic Tolerance of Different High- and Low-flux Dialysis Membranes in Patients Undergoing Chronic Intermittent Hemodialysis: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Ospedale Regionale di Locarno · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dialysis Membranes and Hemodynamic Tolerance

Interventions

Type	Name	Description
DEVICE	Revaclear	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
DEVICE	Helixone high flux	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
DEVICE	Xevonta	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
DEVICE	Helixone low flux	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

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2013-07-12
• Last updated: 2013-07-12

Locations

1 site across 1 country: Switzerland