{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T04:31:12Z","timestamp":1772166672679,"version":"3.50.1"},"reference-count":11,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,6,10]],"date-time":"2020-06-10T00:00:00Z","timestamp":1591747200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,6,10]],"date-time":"2020-06-10T00:00:00Z","timestamp":1591747200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100007658","name":"Baxter Healthcare Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007658","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pilot Feasibility Stud"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>It has been estimated that automated peritoneal dialysis (APD) is currently the fastest growing renal replacement therapy in the world. However, in light of the growing number of diabetic patients on peritoneal dialysis (PD), the unwanted glucose absorption during APD remains problematic. Recent results, using an extended 3-pore model of APD, indicated that large reductions in glucose absorption are possible by using optimized bi-modal treatment regimens, having \u201cUF cycles\u201d using a higher glucose concentration, and \u201cClearance cycles\u201d using a low concentration or, preferentially, no glucose. The present study is designed to test the theoretical prediction of a lower glucose absorption using these novel regimes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This study is a randomized single-center, open-label, prospective study. Prevalent PD patients between 18 and 75\u2009years old without known catheter problems or recent peritonitis are eligible for inclusion. Patients are allocated to a first treatment session of either standard APD (6 \u00d7 2\u2009L 1.36% over 9\u2009h) or optimized APD (7 \u00d7 2\u2009L 2.27% + 5 \u00d7 2\u2009L 0.1% over 8\u2009h). A second treatment session using the other treatment will be performed in a crossover fashion. Samples of the dialysis fluid will be taken before and after the treatment, and the volume of the dialysate before and after the treatment will be carefully assessed. The primary endpoint is difference in glucose absorption between the optimized and standard treatment. Secondary endpoints are ultrafiltration, sodium removal, Kt\/V urea, and Kt\/V Creatinine. The study will be closed when a total of 20 patients have successfully completed the interventions or terminated according to interim analysis. A Monte Carlo power analysis shows that the study has 80% power to detect a difference of 10\u2009g (in line with that of theoretical results) in glucose absorption between the two treatments in 10 patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The present study is the first clinical investigation of optimized bi-modal treatments proposed by recent theoretical studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04017572\">NCT04017572<\/jats:ext-link>\n                      . Registration date: July 12, 2019, retrospectively registered.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s40814-020-00620-2","type":"journal-article","created":{"date-parts":[[2020,6,10]],"date-time":"2020-06-10T03:02:50Z","timestamp":1591758170000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): study protocol for a randomized controlled crossover trial"],"prefix":"10.1186","volume":"6","author":[{"given":"Karin","family":"Bergling","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Javier","family":"de Arteaga","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabi\u00e1n","family":"Ledesma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2471-6914","authenticated-orcid":false,"given":"Carl Mikael","family":"\u00d6berg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,6,10]]},"reference":[{"key":"620_CR1","doi-asserted-by":"crossref","unstructured":"Xue C, Gu YY, Cui CJ, Zhou CC, Wang XD, Ruan MN, et al. New-onset glucose disorders in peritoneal dialysis patients: A meta-analysis andsystematic review. Nephrol Dial Transplant. 2019.","DOI":"10.1093\/ndt\/gfz116"},{"key":"620_CR2","doi-asserted-by":"crossref","unstructured":"\u00d6berg CM, Rippe B. Optimizing automated peritoneal dialysis using an extended 3-pore model. Kidney Int Rep. 2017;2:943\u201351.","DOI":"10.1016\/j.ekir.2017.04.010"},{"key":"620_CR3","doi-asserted-by":"crossref","unstructured":"Heimburger O, Waniewski J, Werynski A, Lindholm B. A quantitative description of solute and fluid transport during peritoneal dialysis. Kidney Int.1992;41:1320\u201332.","DOI":"10.1038\/ki.1992.196"},{"key":"620_CR4","doi-asserted-by":"crossref","unstructured":"Ates K, Nergizoglu G, Keven K, Sen A, Kutlay S, Erturk S, et al. Effect of fluid and sodium removal on mortality in peritoneal dialysis patients. KidneyInt. 2001;60:767\u201376.","DOI":"10.1046\/j.1523-1755.2001.060002767.x"},{"key":"620_CR5","doi-asserted-by":"crossref","unstructured":"Boyle SM, Li Y, Wilson FP, Glickman JD, Feldman HI. Association of alternative approaches to normalizing peritoneal dialysis clearance with mortalityand technique failure: A retrospective analysis using the united states renal data system-dialysis morbidity and mortality study, wave 2. Perit Dial Int. 2017;37:85\u201393.","DOI":"10.3747\/pdi.2015.00227"},{"key":"620_CR6","doi-asserted-by":"crossref","unstructured":"Bargman JM. We use kt\/v urea as a measure of adequacy of peritoneal dialysis. Seminars in Dialysis. 2016;29:258\u20139.","DOI":"10.1111\/sdi.12504"},{"key":"620_CR7","doi-asserted-by":"crossref","unstructured":"Morelle J, Sow A, Fustin CA, Fill\u00e9e C, Garcia-Lopez E, Lindholm B, et al. Mechanisms of crystalloid versus colloid osmosis across the peritonealmembrane. J Am Soc Nephrol. 2018;29:1875\u201386.","DOI":"10.1681\/ASN.2017080828"},{"key":"620_CR8","doi-asserted-by":"crossref","unstructured":"Borrelli S, La Milia V, De Nicola L, Cabiddu G, Russo R, Provenzano M, et al. Sodium removal by peritoneal dialysis: A systematic review and metaanalysis.J Nephrol. 2018.","DOI":"10.1007\/s40620-018-0507-1"},{"key":"620_CR9","doi-asserted-by":"crossref","unstructured":"Kalim S, Wald R, Yan AT, Goldstein MB, Kiaii M, Xu D, et al. Extended duration nocturnal hemodialysis and changes in plasma metabolite profiles.Clin J Am Soc Nephrol. 2018;13:436\u201344.","DOI":"10.2215\/CJN.08790817"},{"key":"620_CR10","doi-asserted-by":"crossref","unstructured":"Rippe B, Oberg CM. Albumin turnover in peritoneal and hemodialysis. Semin Dial. 2016;29:458\u201362.","DOI":"10.1111\/sdi.12534"},{"key":"620_CR11","doi-asserted-by":"crossref","unstructured":"Dolinina J, Rippe A, Bentzer P, Oberg CM. Glomerular hyperpermeability after acute unilateral ureteral obstruction: Effects of tempol, nos, rhoa, andrac-1 inhibition. Am J Physiol Renal Physiol. 2018;315:F445\u201353.","DOI":"10.1152\/ajprenal.00610.2017"}],"container-title":["Pilot and Feasibility Studies"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s40814-020-00620-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s40814-020-00620-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s40814-020-00620-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,6,9]],"date-time":"2021-06-09T19:27:17Z","timestamp":1623266837000},"score":1,"resource":{"primary":{"URL":"https:\/\/pilotfeasibilitystudies.biomedcentral.com\/articles\/10.1186\/s40814-020-00620-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,6,10]]},"references-count":11,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["620"],"URL":"https:\/\/doi.org\/10.1186\/s40814-020-00620-2","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.2.24303\/v1","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.2.24303\/v2","asserted-by":"object"}]},"ISSN":["2055-5784"],"issn-type":[{"value":"2055-5784","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,6,10]]},"assertion":[{"value":"20 February 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 May 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 June 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The local ethics board at the Hospital Privado Universitario (CIEIS) approved the current version (version 1) of the protocol February 11, 2019. The regional ethics board approved the study protocol May 27, 2019.All outpatients will be assessed for inclusion. If none of the pre-allocation exclusion criteria are met, a member of the research team will provide both oral and written information before allocation (\n                      \n                      ). All patients will be given sufficient time to ask questions and to decide whether to participate in the study. Patients are informed of their right to withdraw from the study at any time. A patient who withdraws consent receives standard care. In addition, the patient\/participant may be permanently withdrawn at the treating physician\u2019s or the investigator\u2019s discretion at any time if this is considered to be in the patient\u2019s best interest. A record is kept of patients who consented in the pre-enrolment screening but were never enrolled (patient allocation log).","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Neither the current study protocol nor a future publication will contain any individual person\u2019s data in any form.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"CM\u00d6 has worked as a consultant and received speakers\u2019 honoraria from the Baxter Healthcare Corporation. KB is currently pursuing a master thesis project in collaboration with Gambro Lundia AB (part of Baxter Healthcare Corporation).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"81"}}