Clinical effectiveness of a Malaysian-manufactured CAPD product: A randomised trial. Issue 3 (May 2021)

• Record Type: Journal Article
• 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
• Is Part Of: Peritoneal dialysis international. Volume 41:Issue 3(2021)
• Page Start: 273
• Page End: 283
• Publication Date: 2021-05
• Subjects: Creatinine clearance -- device defect -- Kt/V -- peritoneal dialysis -- peritonitis -- plasticiser -- ultrafiltration rate; Peritoneal dialysis -- Periodicals; Continuous ambulatory peritoneal dialysis -- Periodicals; 617.461059
• DOI: 10.1177/0896860821993954
• Languages: English
• ISSNs: 0896-8608

Abstract

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.