Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2012-10-31
2013-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Revaclear
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
Helixone high flux
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
Xevonta
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
Helixone low flux
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
Interventions
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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
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
95 Years
ALL
No
Sponsors
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Ospedale Regionale di Locarno
OTHER
Responsible Party
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Luca Gabutti, MD
Prof, Head of Department of Internal Medicine
Principal Investigators
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Luca Gabutti, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale Regionale Locarno
Locations
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Ospedale Regionale di Locarno
Locarno, Canton Ticino, Switzerland
Countries
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Other Identifiers
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012012
Identifier Type: -
Identifier Source: org_study_id
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