A Phase 4 interventional study of FX-class of dialyser in Kidney Failure, Chronic, sponsored by Sir Charles Gairdner Hospital. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-04-25.
Sponsored by Sir Charles Gairdner Hospital · Phase 4, Interventional, and Treatment
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:
Methods Patient selection All patients in the Joondalup Health Campus satellite dialysis unit will be invited to participate in this study.
Inclusion criteria -
Exclusion criteria -
Design This study will involve an unblinded, cross-over design, with patients being randomised upon entry into one of 2 groups. The 2 groups will be - 1. HF80 dialyser (this is the best of the currently used dialysers and therefore no participant will require a reduction in their dialysis during this trial); and 2. FX dialyser. Patients will have baseline tests performed prior to intervention and then repeated after 3 months. At 3 months, patients will then cross-over into the other group and tests repeated after a further 6 months.
Due to the nature of the intervention, blinding will not be practical. The cross-over design will allow maximum power for this fixed and relatively small dialysis population (\~50 patients).
Independent variables -
Dialysis prescription on enrolment
a. Including dialyser type (biocompatibility)
Adequacy of dialysis
Anaemia
Calcium phosphate balance
a. Including Parathyroid hormone levels
Outcome markers -
Quality of Life (i) KD-QOL - this is a standardised quality of life questionnaire designed and validated for dialysis patients, that will be readily comparable to other studies.
(ii) Feeling thermometer
Statistical analysis:
Quality of life measures and inflammatory markers will be analysed using paired t-test after normality demonstrated. Simple and multiple linear regression analysis will then be performed to examine associations between independent variables with changes in the outcome variables. STATA 8.2 will be used to assist with the analysis
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 50 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Sir Charles Gairdner Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
KD-QOL
Feeling Thermometer
IL-6
TNF-alpha
hs-CRP
white cell count
This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.
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Sir Charles Gairdner Hospital