Dialysis Membranes and Hemodynamic Tolerance

Not Applicable

Completed

• Conditions: Dialysis Membranes and Hemodynamic Tolerance
• Interventions: Device: Revaclear; Device: Helixone high flux; Device: Xevonta; Device: Helixone low flux

• Registration Number: NCT01898234
• Lead Sponsor: Ospedale Regionale di Locarno

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-07
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-09
• Last Update Submitted: 2013-07-09
• Study First Posted: 2013-07-12
• Last Update Posted: 2013-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Revaclear	Revaclear	-
Helixone high flux	Helixone high flux	-
Xevonta	Xevonta	-
Helixone low flux	Helixone low flux	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
comparative analysis of the incidence of symptomatic and non-symptomatic systolic pressure drops (> 20 mmHg)	4 weeks

Trial Locations

Locations (1)

Ospedale Regionale di Locarno; 🇨🇭 Locarno, Ticino, Switzerland