Chronic Kidney Disease Clinical Trial
Official title:
Study to Assess Clearances and Bio-compatibility of ELISIO Dialyzer
Today, haemodialysis is a recognized standard treatment for patients with chronic kidney
disease stage 5. During the haemodialysis treatment session, blood passes from the patient
through the extracorporeal circuit and is then returned. The dialyzer represents the
greatest surface are of the extracorporeal circuit, as dialysis treatment is essentially
based on the removal of small molecular weight solutes down along a concentration gradient,
and this depends upon surface area. The ELISIO-H dialyzer differs in design to our current
standard dialyzer, the FX100, by having fibers of a greater internal diameter, which
potentially allows more internal haemofiltration, leading to an improved clearance of larger
molecular weight solutes. It is now thought that these so called "middle molecular weight"
solutes are more important in contributing to the clinical condition termed azotaemia,
rather than smaller solutes such as urea.
The investigators therefore wish to study the clearance of middle sized molecules between
the different dialyzers.
Stable chronic kidney dialysis patients, currently dialyzing on the main Royal Free hospital
dialysis unit will be asked to participate in the study. It is aimed to recruit 15 patients
currently dialysing using the Fresenius FX100 dialyzer, who have used Fresenius polysulphone
membranes for > 3 months.
During a mid week dialysis session, dialysis adequacy will be assessed by on line clearance,
and samples of both blood and dialysate taken to assess, both clearances and
bio-compatibility.
Thereafter patients would be switched to dialyse using the ELISIOTM-H dialyzer, but continue
with the same dialysis prescription, and after 3 months, measurements repeated
Assessments Primary Clearances : on-line Kt/V, dual pool Kt/V, phosphate, b2microglobulin,
cystatin C Secondary Serum :isoprostane generation complement activation platelet activation
- coagulation activation - thrombophilic markers - Other Anticoagulation requirements &
clotted circuits erythropoietin requirements, phosphate control therapy CRP
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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