None listed
Conditions
Brief summary
This study examines the biochemical effects of two different dialysis modes. Surprisingly, this has not been well covered in the literature, despite both modes having been practiced for 20+ years. As a secondary feature it also compares two different dialysis membranes utilised in these dialysis modes.
Interventions
2X2 Crossover study - comparison of 2 different dialysis membranes plus comparison of NHD vs HDF.
Baseline status (prior to first study treatment): Nocturnal haemodialysis (8 hour sessions, 3.5x per week) - performed at home, using Fresenius Cordiax dialysers.
Randomisation 1: randomised to either remain on the Fresenius Cordiax dialysers OR to change to Nipro Elisio dialysers - of similar surface area.
Randomisation 2: enter cross-over trial of either NHD followed by HDF or vice versa; both
2X2 Crossover study - comparison of 2 different dialysis membranes plus comparison of NHD vs HDF. Baseline status (prior to first study treatment): Nocturnal haemodialysis (8 hour sessions, 3.5x per week) - performed at home, using Fresenius Cordiax dialysers. Randomisation 1: randomised to either remain on the Fresenius Cordiax dialysers OR to change to Nipro Elisio dialysers - of similar surface area. Randomisation 2: enter cross-over trial of either NHD followed by HDF or vice versa; both with a 2 week washout (regular nocturnal HD) in between. The study session will be the last dialysis session of each 2-week study period (NHD and HDF): for NHD this study session will be performed in the Home training unit. Trial comparator: Haemodiafiltration (4 hour sessions, 3x per week) - performed in the Home Dialysis Training Unit under nurse supervision. Study periods are 2 weeks each, with the last session in the 2-week period being the tested session. There is a 2 week washout between the two periods, wherein patients return to their baseline (NHD) treatment pattern. For the 2-week NHD study period, patients will have 3x per week dialysis (rather than 3.5x) to allow closer comparison.
Sponsors
Prof Peter Kerr
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 85 Years
Healthy volunteers
No
Inclusion criteria
existing nocturnal haemodialysis patients have been stable on NHD for at least 3 months permanent vascular access
Exclusion criteria
planned transplant not able to provide consent not able to adhere to protocol
Outcome results
None listed