Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
One bag for nocturnal (long-dwell) exchange.
One to three, daily (short-dwell) exchanges
Department of Nephrology, University of Chieti
Chieti, Italy
Daily ultrafiltration volume
Change from baseline
Time frame: 28 days
Peritoneal equilibration test
Change from baseline
Time frame: 28 days
Weekly total urea Kt/V
Change from baseline
Time frame: 28 days
Weekly total creatinine clearance
Change from baseline
Time frame: 28 days
Adverse Events
Information about all adverse events, whether volunteered by the patient, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded and followed as appropriate.
Time frame: 2 months
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