Dialysis Membranes and Hemodynamic Tolerance
Conditions
Keywords
Hemodynamics, intradialytic hypotension, subjective tolerance, dialysis membranes, high flux, low flux, hemodialysis
Brief 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.
Interventions
DEVICERevaclear
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
DEVICEHelixone 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
DEVICEXevonta
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
DEVICEHelixone 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
Sponsors
Ospedale Regionale di Locarno
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| comparative evaluation of mean hemodynamic parameters (i.e. systolic and diastolic blood pressure, peripheral resistance and cardiac output) during dialysis | 4 weeks | — |
| comparative evaluation of subjective tolerance across the various membranes | 4 weeks | 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 |
| comparative evaluation of Kt/V and of beta-2 microglobulin removal | 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| comparative analysis of the incidence of symptomatic and non-symptomatic systolic pressure drops (> 20 mmHg) | 4 weeks |
Countries
Switzerland
Outcome results
None listed