Dialysis Membranes and Hemodynamic Tolerance

Study Overview
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Brief Summary
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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.

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

Conditions
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Dialysis Membranes and Hemodynamic Tolerance

Intervention / Treatment
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* Device: Revaclear
* Device: Helixone high flux
* Device: Xevonta
* Device: Helixone low flux


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revaclear<br> | Device: Revaclear<br>* 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<br>* Other names: -Revaclear, Gambro 1.8 m2;|
| Experimental: Helixone high flux<br> | Device: Helixone high flux<br>* 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<br>* Other names: Helixone high flux, Fresenius 1.8 m2;|
| Experimental: Xevonta<br> | Device: Xevonta<br>* 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<br>* Other names: Xevonta, BBraun 1.8 m2;|
| Experimental: Helixone low flux<br> | Device: Helixone low flux<br>* 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<br>* Other names: Helixone low flux, Fresenius 1.8 m2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 4 weeks | 
| comparative evaluation of Kt/V and of beta-2 microglobulin removal |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparative analysis of the incidence of symptomatic and non-symptomatic systolic pressure drops (> 20 mmHg) |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodynamics, intradialytic hypotension, subjective tolerance, dialysis membranes, high flux, low flux, hemodialysis