NCT01898234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
Last Updated

July 12, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

July 2, 2013

Last Update Submit

July 9, 2013

Conditions

Dialysis Membranes and Hemodynamic Tolerance

Keywords

Hemodynamicsintradialytic hypotensionsubjective tolerancedialysis membraneshigh fluxlow fluxhemodialysis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

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

    4 weeks

Study Arms (4)

Revaclear

EXPERIMENTAL
Device: Revaclear

Helixone high flux

EXPERIMENTAL
Device: Helixone high flux

Xevonta

EXPERIMENTAL
Device: Xevonta

Helixone low flux

EXPERIMENTAL
Device: Helixone low flux

Interventions

RevaclearDEVICE

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

Also known as: -Revaclear, Gambro 1.8 m2
Revaclear
Helixone high fluxDEVICE

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

Also known as: Helixone high flux, Fresenius 1.8 m2
Helixone high flux
XevontaDEVICE

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

Also known as: Xevonta, BBraun 1.8 m2
Xevonta
Helixone low fluxDEVICE

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

Also known as: Helixone low flux, Fresenius 1.8 m2
Helixone low flux

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Regionale di Locarno

Locarno, Canton Ticino, 6928, Switzerland

Location

Study Officials

  • Luca Gabutti, MD

    Ospedale Regionale Locarno

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof, Head of Department of Internal Medicine

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 12, 2013

Study Start

October 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 12, 2013

Record last verified: 2013-07

Locations

CH(1)