Dialysis Membranes and Hemodynamic Tolerance

Sponsor

Ospedale Regionale di Locarno (Other)

Overall Status

Completed

CT.gov ID

NCT01898234

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dialysis Membranes and Hemodynamic Tolerance	Device: Revaclear Device: Helixone high flux Device: Xevonta Device: Helixone low flux	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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