An interventional study of Revaclear and Helixone high flux in Dialysis Membranes and Hemodynamic Tolerance, sponsored by Ospedale Regionale di Locarno. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2013-07-12.
Sponsored by Ospedale Regionale di Locarno · Not applicable, Interventional, and Treatment
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.
Ospedale Regionale di Locarno is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Revaclear
Device: Helixone high flux
Device: Xevonta
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
Also known as: -Revaclear, Gambro 1.8 m2
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
Also known as: Helixone high flux, Fresenius 1.8 m2
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
Also known as: Xevonta, BBraun 1.8 m2
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
Also known as: Helixone low flux, Fresenius 1.8 m2
comparative evaluation of mean hemodynamic parameters (i.e. systolic and diastolic blood pressure, peripheral resistance and cardiac output) during dialysis
Time frame: 4 weeks
comparative evaluation of subjective tolerance across the various membranes
As to the assessment of subjective tolerance, we decided to administer the questionnaire designed by Cruz et al. \[Cruz DN, Mahnensmith RL, Brickel HM, Perazella MA. Midodrine and cool dialysate are effective therapies for symptomatic intradialytic hypotension. Am. J. Kidney Dis. 1999 Mag;33(5):920-926\] then modified by Teruel et al. \[Teruel JL, Martins J, Merino JL, Fernández Lucas M, Rivera M, Marcén R, et al. Temperature of the dialysis bath and hemodialysis tolerance. Nefrología: PublicaciónOficial De La Sociedad Española Nefrologia. 2006;26(4):461-468\] and to integrate it with a 1 to 10 numerical scale to assess patient well-being
Time frame: 4 weeks
comparative evaluation of Kt/V and of beta-2 microglobulin removal
Time frame: 4 weeks
comparative analysis of the incidence of symptomatic and non-symptomatic systolic pressure drops (> 20 mmHg)
Time frame: 4 weeks
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Ospedale Regionale di Locarno