Dialysis Membranes and Hemodynamic Tolerance

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

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.

Study Overview

• Status: Completed
• Conditions: Dialysis Membranes and Hemodynamic Tolerance
• Intervention / Treatment: Device: Revaclear; Device: Helixone high flux; Device: Xevonta; Device: Helixone low flux

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Ticino
    • Locarno, Ticino, Switzerland, 6928
      • Ospedale Regionale di Locarno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 91 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Revaclear	Device: 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; Other Names: -Revaclear, Gambro 1.8 m2
Experimental: Helixone high flux	Device: 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; Other Names: Helixone high flux, Fresenius 1.8 m2
Experimental: Xevonta	Device: 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; Other Names: Xevonta, BBraun 1.8 m2
Experimental: Helixone low flux	Device: 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 Names: Helixone low flux, Fresenius 1.8 m2

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ospedale Regionale di Locarno
• Investigators: Principal Investigator: Luca Gabutti, MD, Ospedale Regionale Locarno

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (Estimate): July 12, 2013

Study Record Updates

• Last Update Posted (Estimate): July 12, 2013
• Last Update Submitted That Met QC Criteria: July 9, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: hemodialysis; Hemodynamics; intradialytic hypotension; subjective tolerance; dialysis membranes; high flux; low flux
• Other Study ID Numbers: 012012