Clinical effectiveness of a Malaysian-manufactured CAPD product: A randomised trial.
Perit Dial Int
; 41(3): 273-283, 2021 05.
Article
em En
| MEDLINE
| ID: mdl-33733911
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 11 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Peritonite
/
Diálise Peritoneal
/
Diálise Peritoneal Ambulatorial Contínua
Tipo de estudo:
Clinical_trials
/
Etiology_studies
Limite:
Adult
/
Humans
Idioma:
En
Revista:
Perit Dial Int
Assunto da revista:
NEFROLOGIA
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Malásia