{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T03:39:48Z","timestamp":1785555588322,"version":"3.56.0"},"reference-count":18,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T00:00:00Z","timestamp":1772064000000},"content-version":"unspecified","delay-in-days":25,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004731","name":"Zhejiang Natural Science Foundation","doi-asserted-by":"crossref","award":["LQ24H270045"],"award-info":[{"award-number":["LQ24H270045"]}],"id":[{"id":"10.13039\/501100004731","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100004731","name":"Zhejiang Natural Science Foundation","doi-asserted-by":"crossref","award":["Y23H270009"],"award-info":[{"award-number":["Y23H270009"]}],"id":[{"id":"10.13039\/501100004731","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Scientific Research Programme of Zhejiang Traditional Chinese Medicine Administry and National Traditional Chinese Medicine Administry","award":["GZY-ZJ-KJ-23013"],"award-info":[{"award-number":["GZY-ZJ-KJ-23013"]}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"crossref","award":["82405264"],"award-info":[{"award-number":["82405264"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Zhejiang Provincial Department of Science and Technology Major R&D Breakthrough Project","award":["2025C02190"],"award-info":[{"award-number":["2025C02190"]}]},{"name":"\u8d5b\u5b89\u7279\u79d1\u6280\uff08\u676d\u5dde\uff09\u6709\u9650\u516c\u53f8 (Science And Technology Technology"},{"name":"\u6210\u90fd\u9752\u5c71\u5229\u5eb7\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,1,27]]},"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Peritoneal dialysis (PD) is a widely used renal replacement therapy for chronic kidney disease patients, yet malnutrition remains a common complication linked to poor outcomes. Nearly 40% of PD patients in China are malnourished, with serum albumin levels below 35\u2009g\/L. Amino acid-based peritoneal dialysis solutions (AA-PDS), which replace glucose with amino acids as the osmotic agent, have been used globally for decades to improve nutrition and reduce peritoneal damage, but they were introduced to mainland China only in 2022. This study aims to evaluate the efficacy and safety of AA-PDS in improving nutritional status and clinical outcomes among malnourished PD patients in mainland China, providing a potential new therapeutic option for this population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This multicentre, open-label, prospective, parallel-controlled study will enrol patients with end-stage kidney disease who were stable on PD for more than 3 months. A total of 500 eligible patients will be divided into the intervention group undergoing PD once every morning using 2.0\u2009L of amino acid (15) PD solution and the control group using conventional PD solution (lactate) in a 4:1 ratio based on their willingness and clinical needs. Our primary outcome is serum albumin, while other nutritional indicators, including serum prealbumin, serum transferrin, total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and ultrafiltration volumes are considered secondary outcomes. Information such as demographics, clinical and biochemical characteristics, examination indicators, anthropometry measurements and Subjective Global Assessment scores will be collected at baseline, 1\u2009month, 3\u2009month and 6\u2009month follow-up. Statistical analysis will be conducted using SAS V.9.4 or higher versions. All statistical tests are conducted through the two-tailed test, and a p value\u22640.05\u2009will be considered statistically significant. The description of quantitative indicators will be used in calculating the number of cases, mean, SD, median and IQR method. The classification indicators will be used to describe the number of cases and percentages (frequency and frequency rate).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This multicentre study obtained ethical approval from the lead ethics committee at the First Affiliated Hospital of Zhejiang Chinese Medical University (approval no.: 2024-KLS-379-02). Additionally, each participating site provided local ethical approval or a formal waiver, as required by their institutional policies. The results will be reported in a peer-reviewed journal and a relevant academic conference.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trail registration number<\/jats:title>\n                    <jats:p>ChiCTR2400090896.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-101697","type":"journal-article","created":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T14:15:14Z","timestamp":1772115314000},"page":"e101697","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Multicentre, open-label, prospective, parallel-controlled study protocol evaluating the effects of amino acid peritoneal dialysis solution on nutritional status in Chinese peritoneal dialysis patients"],"prefix":"10.1136","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0165-9176","authenticated-orcid":false,"given":"Jiayue","family":"Zhou","sequence":"first","affiliation":[{"name":"Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China"},{"name":"Department of Internal Medicine, Deqing Hospital of TCM, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenli","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiang","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianjian","family":"Shi","sequence":"additional","affiliation":[{"name":"Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lijuan","family":"Ai","sequence":"additional","affiliation":[{"name":"Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cong","family":"Xia","sequence":"additional","affiliation":[{"name":"Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fan","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaojun","family":"Xiang","sequence":"additional","affiliation":[{"name":"Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiang","family":"He","sequence":"additional","affiliation":[{"name":"Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongbo","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shouci","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,2,26]]},"reference":[{"key":"2026022606150831000_16.2.e101697.1","doi-asserted-by":"crossref","first-page":"779","DOI":"10.1038\/s41581-022-00623-7","article-title":"Epidemiology of peritoneal dialysis outcomes","volume":"18","author":"Bello","year":"2022","journal-title":"Nat Rev 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