A randomized, multicenter, open-label trial to establish therapeutic equivalence between the Carex and ultra disconnect systems in patients on continuous ambulatory peritoneal dialysis.
OBJECTIVE
In the present study, we undertook to establish therapeutic equivalence with respect to peritonitis and technique failure between the Carex disconnect system (B. Braun Carex, Mirandola, Italy) and the standard Ultra system (Baxter Healthcare, Tokyo, Japan) in patients on continuous ambulatory peritoneal dialysis (CAPD).


METHODS
This multicenter, parallel group, randomized controlled trial involved 363 prevalent CAPD patients from 8 centers. The primary endpoint was peritonitis rate; secondary endpoints were technique failure and technical problems encountered. The duration of the evaluation was 1 year.


RESULTS
The risk of peritonitis on Carex varied between the centers. We found a significant treatment-center interaction effect (likelihood ratio test: p = 0.03). The incidence rate ratio (IRR) of peritonitis on Carex as compared with Ultra ranged from 0.4 to 7.2. In two centers, Carex was inferior to Ultra with regard to peritonitis; but, in five centers, the results were inconclusive. Equivalence was not demonstrated in any center. The overall rate of peritonitis in the Carex group was twice that in the Ultra group [IRR: 2.18; 95% confidence interval (CI): 1.51 to 3.14]. Technique failure and technical problems were more common with the Carex system. Technique failure rate at 1 year was 44% in the Carex group and 22% in the Ultra group.


CONCLUSIONS
Equivalence between the Carex disconnect system and the Ultra disconnect system could not be demonstrated. The risk of peritonitis on Carex varied significantly between centers.
Ong
Loke-Meng
LM
Department of Medicine, Penang Hospital, Malaysia.
Lim
Teck-Onn
TO
Hooi
Lai-Seong
LS
Morad
Zaki
Z
Tan
Poh-Choo
PC
Wong
Hin-Seng
HS
Lim
Yam-Ngo
YN
Ghazalli
Rozina
R
Tan
Chwee-Choon
CC
Shaariah
Wan
W
Liew
Boon-Seng
BS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010531:Peritoneal Dialysis, Continuous Ambulatory / Q000295:instrumentation*; D010538:Peritonitis / Q000453:epidemiology*; D055815:Young Adult