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Short Term Effects of FX Dialysers on QOL and Inflammation

NCT00291603 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2007-04-25

No results posted yet for this study

Summary

Background:

The new hollow fibre FX-class of dialysers (Fresenius Medical Care, Bad Homburg, Germany) features a number of technological improvements that may benefit the patient. This includes the use of the advanced high-flux polysulfone membrane, Helixone®, which has an extremely high endotoxin retaining capability. Theoretically leading to reduced systemic inflammation in the patient, which is an important factor for morbidity and mortality with dialysis.

The dialysis membrane is the first to be manufactured using membrane-spinning procedures (nano-controlled spinning technology) that enables the membrane to be modulated at the nano-scale level. The resultant membrane is able to extremely efficiently remove middle molecules, along with minimal loss of albumin.

These features may lead to improved patient outcomes, including reduced systemic inflammation and improved quality of life.

Aims:

1. To assess the short-term effects of the FX-class Dialyser on quality of life in stable haemodialysis patients
2. To assess the short-term effects of the FX-class Dialyser on inflammatory markers in stable haemodialysis patients.

Conditions

  • Kidney Failure, Chronic

Interventions

DEVICE

FX-class of dialyser

Sponsors & Collaborators

  • Sir Charles Gairdner Hospital

    lead OTHER

Principal Investigators

  • Neil C Boudville, MD · The University of Western Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Completion
2006-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00291603 on ClinicalTrials.gov