{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T20:38:26Z","timestamp":1777927106542,"version":"3.51.4"},"reference-count":20,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2021,3,18]],"date-time":"2021-03-18T00:00:00Z","timestamp":1616025600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100013885","name":"Ministry of Health Malaysia","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100013885","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Perit Dial Int"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>We compared the clinical effectiveness of a new peritoneal dialysis (PD) product with polyvinyl chloride-containing tubing (Stay Safe Link\u00ae, SSL) with the plastic-free alternative (Stay Safe\u00ae, STS) in patients on continuous ambulatory peritoneal dialysis (CAPD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method:<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>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\u20131.28). 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 &lt; 0.01). SSL also demonstrated a 2.57-times higher risk of device defect than STS (95% CI: 1.77\u20133.75).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0896860821993954","type":"journal-article","created":{"date-parts":[[2021,3,18]],"date-time":"2021-03-18T05:56:50Z","timestamp":1616047010000},"page":"273-283","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Clinical effectiveness of a Malaysian-manufactured CAPD product: A randomised trial"],"prefix":"10.1177","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8346-2934","authenticated-orcid":false,"given":"Wen Yao","family":"Mak","sequence":"first","affiliation":[{"name":"Clinical Research Centre, Penang Hospital, Ministry of Health Malaysia, George Town, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chin Tho","family":"Leong","sequence":"additional","affiliation":[{"name":"Institute of Clinical Research, National Institute of Health, Ministry of Health Malaysia, Setia Alam, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Loke Meng","family":"Ong","sequence":"additional","affiliation":[{"name":"Department of Medicine, Penang Hospital, Ministry of Health Malaysia, George Town, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sunita","family":"Bavanandan","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Kuala Lumpur Hospital, Ministry of Health Malaysia, Kuala Lumpur, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lily","family":"Mushahar","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Tuanku Ja\u2019afar Hospital, Ministry of Health Malaysia, Seremban, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bak Leong","family":"Goh","sequence":"additional","affiliation":[{"name":"Clinical Research Centre, Serdang Hospital, Ministry of Health Malaysia, Kajang, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4807-7053","authenticated-orcid":false,"given":"Hin Seng","family":"Wong","sequence":"additional","affiliation":[{"name":"Clinical Research Centre, Selayang Hospital, Ministry of Health Malaysia, Selangor, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ghazali","family":"Ahmad","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Kuala Lumpur Hospital, Ministry of Health Malaysia, Kuala Lumpur, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yew Fong","family":"Liew","sequence":"additional","affiliation":[{"name":"Department of Medicine, Penang Hospital, Ministry of Health Malaysia, George Town, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chen Hua","family":"Ching","sequence":"additional","affiliation":[{"name":"Department of Medicine, Sultanah Bahiyah Hospital, Ministry of Health Malaysia, Alor Setar, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wen Jiun","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Medicine, Sultanah Aminah Hospital, Ministry of Health Malaysia, Johor Bahru, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Korina","family":"Rahmat","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Melaka Hospital, Ministry of Health Malaysia, Melaka, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clare Hui-Hong","family":"Tan","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Sarawak General Hospital, Ministry of Health Malaysia, Kuching, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohd Kamil","family":"Ahmad","sequence":"additional","affiliation":[{"name":"Department of Medicine, Tengku Ampuan Afzan Hospital, Ministry of Health Malaysia, Kuantan, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wan Hasnul Halimi Wan","family":"Hassan","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Raja Perempuan Zainab II Hospital, Ministry of Health Malaysia, Kota Bharu, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fei Sia","family":"Chan","sequence":"additional","affiliation":[{"name":"Nephrology Unit, Department of Medicine, Queen Elizabeth Hospital, Ministry of Health Malaysia, Kota Kinabalu, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zaiha","family":"Harun","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Sultanah Nur Zahirah Hospital, Ministry of Health Malaysia, Kuala Terengganu, Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chek Loong","family":"Loh","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Raja Permaisuri Bainun Hospital, 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