Comparison of clinical outcome and ease of handling in two double-bag systems in continuous ambulatory peritoneal dialysis: A prospective, randomized, controlled, multicenter study

Abstract

Background: We performed a prospective, randomized, controlled, multicenter study on the use of two double-bag disconnect systems: Stay-Safe (SS; Fresenius Deutschland GmbH2) and Ultrabag (UB; Baxter Healthcare, Deerfield, IL) to assess the ease of handling, peritonitis rate, exit-site infection rate, and clinical outcome. Methods: We enrolled 110 new continuous ambulatory peritoneal dialysis (CAPD) patients; 55 patients were randomized to SS treatment, and 55 patients, to UB treatment. Results: Patients using the UB and SS systems were followed up for 946 and 846 patient-months, respectively. There were 21 episodes of peritonitis in 18 patients in the UB group and 23 episodes in 18 patients in the SS group. No significant difference was observed in peritonitis rates between the two systems, which were 45 and 36.8 patient-months per episode for the UB and SS groups, respectively. At 12 months, 82.1% of patients in the UB group and 72.1% in the SS group were free of peritonitis; at 18 months, 71.1% and 62.2% were free of peritonitis for the UB and SS groups, respectively (P = 0.559). Gram-positive organisms accounted for 28.6% of infections in the UB group and 39.1% in the SS group. Exit-site infection rates were one episode per 21 patient-months versus 19.2 patient-months in the UB and SS groups, respectively (P = 0.743). Patients perceived SS as easier to handle in 4 of the 13 steps immediately post-CAPD training. However, there was no significant difference in rankings between the two systems after 1 month of adaptation. Median training periods were 4 and 5 days for the SS and UB groups, respectively (P = 0.640). Conclusion: The two double-bag systems (UB and SS) have similar incidences of peritonitis and exit-site infection. Both systems showed comparably good clinical outcome. The SS system is easier to learn during the initial training period, but the difference is not significant after 1 month's adaptation. © 2002 by the National Kidney Foundation, Inc.