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Completed

NCT Number: NCT01898234

Dialysis Membranes and Hemodynamic Tolerance

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.

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Key information

Conditions

Dialysis Membranes and Hemodynamic Tolerance

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Regionale di Locarno

Locarno, Canton Ticino, 6928, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Revaclear

Device

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 names: -Revaclear, Gambro 1.8 m2

Helixone high flux

Device

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 names: Helixone high flux, Fresenius 1.8 m2

Xevonta

Device

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 names: Xevonta, BBraun 1.8 m2

Helixone low flux

Device

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 names: Helixone low flux, Fresenius 1.8 m2

Primary outcomes

  1. comparative evaluation of mean hemodynamic parameters (i.e. systolic and diastolic blood pressure, peripheral resistance and cardiac output) during dialysis

    Time frame: 4 weeks

  2. comparative evaluation of subjective tolerance across the various membranes

    Time frame: 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

  3. comparative evaluation of Kt/V and of beta-2 microglobulin removal

    Time frame: 4 weeks

Secondary outcomes

  1. comparative analysis of the incidence of symptomatic and non-symptomatic systolic pressure drops (> 20 mmHg)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Ospedale Regionale di Locarno

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2013
Registry last updated
Jul 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.