Clinical effectiveness of a Malaysian-manufactured CAPD product: A randomised trial

• Published in: Peritoneal dialysis international Vol. 41; no. 3; pp. 273 - 283
• Main Authors: Mak, Wen Yao, Leong, Chin Tho, Ong, Loke Meng, Bavanandan, Sunita, Mushahar, Lily, Goh, Bak Leong, Wong, Hin Seng, Ahmad, Ghazali, Liew, Yew Fong, Ching, Chen Hua, Liu, Wen Jiun, Rahmat, Korina, Tan, Clare Hui-Hong, Ahmad, Mohd Kamil, Hassan, Wan Hasnul Halimi Wan, Chan, Fei Sia, Harun, Zaiha, Loh, Chek Loong, Teng, Kok Seng, Tye, Yi Loon, Khan, Shahnaz Shah Firdaus, Koh, Keng-Hee, Abdullah, Rafidah, Hooi, Lai Seong
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.05.2021
• Subjects: Adult; Humans; Peritoneal Dialysis; Peritoneal Dialysis, Continuous Ambulatory; Peritonitis - epidemiology; Peritonitis - etiology; Treatment Outcome; Ultrafiltration; Kt/V; Creatinine clearance; plasticiser; peritonitis; ultrafiltration rate; peritoneal dialysis; device defect
• ISSN: 0896-8608; 1718-4304
• DOI: 10.1177/0896860821993954

Background: We compared the clinical effectiveness of a new peritoneal dialysis (PD) product with polyvinyl chloride-containing tubing (Stay Safe Link®, SSL) with the plastic-free alternative (Stay Safe®, STS) in patients on continuous ambulatory peritoneal dialysis (CAPD). Method: A multicentre, parallel, randomised, controlled, open-label, non-inferiority trial was conducted. Adult patients receiving CAPD were randomised in a 1:1 ratio to SSL or STS. The primary outcome was the rate of peritonitis after 1 year of follow-up. Results: A total of 472 subjects were randomised (SSL, n = 233; STS, n = 239). One subject in each group was excluded from the analysis as they withdrew consent before the first dialysis dose. Four hundred and seventy subjects (SSL, n = 232; STS, n = 238) were included in the modified intention-to-treat analysis. Non-inferiority between two groups was established as no significant difference was found in peritonitis rate (incident rate ratio: 0.91, 95% CI: 0.65–1.28). No significant difference was detected in weekly Kt/V (p = 0.58) and creatinine clearance (p = 0.55). However, the average ultrafiltration volume was significantly lower in SSL, with a mean difference of 93 ml (p < 0.01). SSL also demonstrated a 2.57-times higher risk of device defect than STS (95% CI: 1.77–3.75). Conclusion: SSL was non-inferior in peritonitis rate compared to plastic-free STS over 1 year in patients requiring CAPD. There was no difference in the delivered dialysis dose, but there was a higher rate of device defects with SSL.