Ultrafiltration and Sodium Removal in Steady Concentration Peritoneal Dialysis: A Prospective, Multicenter, Randomized, Crossover Study.

Abstract

The study compared the efficacy and safety of steady concentration peritoneal dialysis using the Carry Life UF system in the home setting over 4 weeks. Treatment with the Carry Life UF system resulted in increased ultrafiltration volume, sodium removal, and glucose ultrafiltration efficiency compared with a 2.5% dextrose control. The use of Carry Life UF in the home setting was well tolerated and safe with no unexpected adverse events. Steady concentration peritoneal dialysis (PD) is a novel therapy for improved fluid management. We compared the efficacy and safety of steady concentration PD using the Carry Life UF system with a standard 2.5% dextrose continuous ambulatory peritoneal dialysis exchange in the home setting. This is a prospective, multicenter, randomized, crossover study of adult patients on continuous ambulatory peritoneal dialysis using 2-4 exchanges per day, with at least one daily 2.5% dextrose exchange. The home phase lasted 4 weeks for each study arm. During the Carry Life UF arm, one daily 2.5% dextrose exchange was replaced with a Carry Life UF treatment 3 days/wk (1.5% dextrose solution for PD fill, 11 or 15 g/h glucose dose) and a 1.5% dextrose exchange 4 days/wk. The primary outcome was difference in ultrafiltration (UF) volume with 5-hour Carry Life UF treatment versus 5-hour 2.5% dextrose exchange (control). Secondary outcomes included adverse events, peritoneal sodium removal, and glucose UF efficiency. A total of 19 participants (mean [SD] age 56 [15] years, six women, seven with diabetes) completed the study. Peritoneal solute transfer rate categories were fast four, average 12, and slow three. The UF volume primary outcome was met as Carry Life UF was superior to control in a prespecified superiority margin of 250 ml, mean increase 381 ml, 95% confidence interval (CI; 285 to 477). For the Carry Life UF total group (11 and 15 g/h cohorts analyzed together), mean (SD) UF volume was 513 (251) versus 132 (172) ml for the control. The secondary outcome peritoneal sodium removal was greater with Carry Life UF versus control (mean increase 43 mmol/exchange, 95% CI 32 to 54). The secondary outcome glucose UF efficiency (UF volume in relation to glucose absorption) was enhanced with Carry Life UF versus control (mean increase 6.4 ml/g, 95% CI 3.7 to 9.1). Two serious adverse events (peritonitis) occurred in the home phase, one episode in each study arm. This 4-week home study of steady concentration PD using the Carry Life UF system demonstrated efficacy and safety. NCT05874804.