None listed
Conditions
Brief summary
This trial examines the safety and efficacy of a (relatively) new haemodialysis membrane in the setting of extended hours (nocturnal) haemodialysis, compared to an existing, commonly used membrane. The company has no data on the toxin clearance with this membrane in this setting. Extended hours dialysis offers improved clearances of toxins, compared to conventional 4-hour dialysis, hence it is appropriate to assess the performance of these membranes in the setting of nocturnal HD/Extended hours HD. Both dialysis membranes used are commercially available. Outcome measures include clearances for uremic toxins (eg. urea, creatinine, phosphate, and indoxyl sulfate) and safety measures such as haematology indices: - full-blood examination and clotting, and biocompatibility indices (Interleukin-6 - known as IL-6).
Interventions
Extended hours (nocturnal) haemodialysis, using 2 different dialysis membranes.
Dialysis will be performed as per the patients' usual prescription (usually alternate day, 7-8 hours per session). No changes to the prescription will be made for the trial or during the trial; except for the membrane.
Patients will be randomly assigned to a sequence of the 2 membranes (details of membranes below). There will be no washout between the membranes but the test membrane will be in the mid-week session
Extended hours (nocturnal) haemodialysis, using 2 different dialysis membranes. Dialysis will be performed as per the patients' usual prescription (usually alternate day, 7-8 hours per session). No changes to the prescription will be made for the trial or during the trial; except for the membrane. Patients will be randomly assigned to a sequence of the 2 membranes (details of membranes below). There will be no washout between the membranes but the test membrane will be in the mid-week session of the 4th week of each membrane. Each membrane will be tested for 4 weeks. The regular dialysis sessions will occur at the patients' homes. Records of the home dialysis sessions will be reviewed to ensure membrane choice and dialysis parameters have been adhered to. The test dialysis sessions (mid-week, 4th week of each membrane) will occur under nursing supervision at the home-dialysis training unit. During the test dialysis session, blood and dialysate collections will be taken to assess clearance of solutes and levels of biocompatibility markers. The FX80 dialysis membrane (polysulfone), as the currently used standard, will be the comparator/control membrane. The Nipro Solacia membrane (asymmetrical cellulose triacetate) will be the test membrane.
Sponsors
Monash Health, Clayton, Vic,
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Existing nocturnal haemodialysis patients.
Exclusion criteria
Those with dialysis difficulties, such as poor Arterio-venous access. Those unwilling to consent.
Outcome results
None listed