In vitro and in vivo efficacy of a new connector device for continuous ambulatory peritoneal dialysis.

The purpose of this study was to evaluate the in vitro and in vivo efficacy of a new connection system for continuous ambulatory peritoneal dialysis (CAPD), called the T-set. With this system the patient wears a 27-cm extension line filled with Amuchina during the dwell time; the bag is made of a fill container linked to a drainage tube with a Y-shaped set. For bag exchange, only one connection is needed and this is subsequently flushed with the entire drainage volume. The in vitro efficacy of the system was tested with 20 sets filled with 10 mL of Amuchina and inoculated in the distal lumen with 2.1 x 10(3) colony-forming units (cfu) of S. aureus. After an incubation of 4-6 hours at 35-37 degrees C, three dialysate samples per set were collected, respectively, at the beginning of drainage and filling. All 120 samples were negative, whereas two control sets, filled with a phosphate-buffered saline, had positive drainage samples, and at least one positive infusion sample, indicating the efficacy of Amuchina in sterilizing the system under conditions simulating touch contamination. To evaluate the in vivo efficacy, safety, and acceptability of the T-system, a prospective randomized controlled trial was performed in seven centers: a control group (CG) of 56 patients (follow-up: 952.3 months, mean +/- SD: 17.0 +/- 7.8) was treated with a long branch (21 patients) or short branch (35 patients) Y-set and a test group (TG) of 66 patients (follow-up:898.1 months, mean +/- SD: 13.6 +/- 7.8) with the T-set.(ABSTRACT TRUNCATED AT 250 WORDS)

Design and testing of the Baxter Integrated Disconnect Systems (IDS).

This paper describes the result of a miltidisciplinary approach to the design and evaluation of a new CAPD disconnect system: the Baxter Integrated Disconnect System (IDS). This system consists of a bag full of fresh Dianeal, an empty bag for the drainage of spent dialysate and tubings connecting the 2 in a Y fashion. With this system, the patient makes only one connection. The system is disposable. The major property that makes this unique is that all components are preassembled, and the whole system is steam-sterilized as 1 unit. In general, similar systems use different sterilization methods for the various components of the system. Those components are then assembled, under clean conditions by the manufacturer, without final sterilization of the unit. Assembly of the components is sometimes left to the patient. The concept of IDS, therefore, is unique and warrants lower rates of contamination. This system has been tested on patients for a total observation period of 765 patient months, and has proven to be simple, safe and effective. It yields a 63% probability of peritonitis-free patients at 24 months.