{"id":2082,"date":"2024-07-17T09:40:48","date_gmt":"2024-07-17T09:40:48","guid":{"rendered":"https:\/\/hub.salford.ac.uk\/applied-health-research\/?page_id=2082"},"modified":"2024-07-30T10:01:48","modified_gmt":"2024-07-30T10:01:48","slug":"the-bistro-trial","status":"publish","type":"page","link":"https:\/\/hub.salford.ac.uk\/applied-health-research\/long-term-conditions\/the-bistro-trial\/","title":{"rendered":"BioImpedance Spectroscopy to Maintain Renal Output: The BISTRO Trial"},"content":{"rendered":"\n<p><strong>Background<\/strong><\/p>\n\n\n\n<p>Preserved Residual Kidney Function (RKF) and normal fluid status are associated with better patient outcomes in incident haemodialysis patients. The objective of this trial is to determine whether using bioimpedance technology in prescribing the optimal post-dialysis weight can reduce the rate of decline of RKF and potentially improve patient outcomes.<\/p>\n\n\n\n<p>Professor Paula Ormandy from the University of Salford was a co-Investigator on this trial.<\/p>\n\n\n\n<p><strong>Methods\/Design<\/strong><\/p>\n\n\n\n<p>516 patients commencing haemodialysis, aged &gt;18 with RKF of\u2009&gt;\u20093&nbsp;ml\/min\/1.73&nbsp;m<sup>2<\/sup>&nbsp;or a urine volume &gt;500&nbsp;ml per day or per the shorter inter-dialytic period will be consented and enrolled into a pragmatic, open-label, randomized controlled trial. The intervention is incorporation of bioimpedance spectroscopy (BI) determination of normally hydrated weight to set a post-dialysis target weight that limits volume depletion, compared to current standard practice. Clinicians and participants will be blinded to BI measures in the control group and a standardized record capturing management of fluid status will be used in all participants. Primary outcome is preservation of residual kidney function assessed as time to anuria (\u2264100&nbsp;ml\/day or \u2264200&nbsp;ml urine volume in the short inter-dialytic period). A sample size of 516 was based upon a cumulative incidence of 30% anuria in the control group and 20% in the treatment group and 11% competing risks (death, transplantation) over 10&nbsp;months, with up to 2&nbsp;years follow-up.<\/p>\n\n\n\n<p>Secondary outcomes include rate of decline in small solute clearance, significant adverse events, hospitalization, loss of vascular access, cardiovascular events and interventions, dialysis efficacy and safety, dialysis-related symptoms and quality of life. Economic evaluation will be carried out to determine the cost-effectiveness of the intervention. Analyses will be adjusted for patient characteristics and dialysis unit practice patterns relevant to fluid management.<\/p>\n\n\n\n<p><strong>Discussion<\/strong><\/p>\n\n\n\n<p>This trial will establish the added value of undertaking BI measures to support clinical management of fluid status and establish the relationship between fluid status and preservation of residual kidney function in incident haemodialysis patients.<\/p>\n\n\n\n<p><strong>Funder<\/strong><\/p>\n\n\n\n<p>National Institute for Health Research (NIHR) Health Technology Assessment (HTA) assessment<\/p>\n\n\n\n<p><strong>Team&nbsp;<\/strong>&nbsp;<\/p>\n\n\n\n<p><strong>Principal Invetsigator:<\/strong><\/p>\n\n\n\n<p>Simon J. Davies (PI)&nbsp;<\/p>\n\n\n\n<p><strong>Co-Investigators:<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/salford-repository.worktribe.com\/person\/1153645\/paula-ormandy\">Paula Ormandy<\/a>, School of Health &amp; Society, University of Salford<\/p>\n\n\n\n<p><strong>Ivonne Solis-Trapala&nbsp;&amp;&nbsp;Julius Sim<\/strong>, Institute for Applied Clinical Sciences, Keele University, Keele, Staffordshire, UK<\/p>\n\n\n\n<p><strong>Fergus J. Caskey<\/strong>, UK Renal Registry and School of Social and Community Medicine, University of Bristol, Bristol, UK<\/p>\n\n\n\n<p><strong>David Coyle,&nbsp;Elizabeth Lindley&nbsp;&amp;&nbsp;Sandip Mitra<\/strong>, NIHR Devices for Dignity, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK<\/p>\n\n\n\n<p><strong>Elizabeth Lindley<\/strong>, Renal Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK<\/p>\n\n\n\n<p><strong>Jamie Macdonald<\/strong>, School of Sport, Health and Exercise Sciences, Bangor University, Bangor, North Wales, UK<\/p>\n\n\n\n<p><strong>Sandip Mitra<\/strong>, Renal Medicine, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK<\/p>\n\n\n\n<p><strong>Martin Wilkie<\/strong>, Renal Medicine, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK<\/p>\n\n\n\n<p><strong>Andrew Davenport<\/strong>, Renal Medicine, Royal Free Hampstead NHS Trust, London, UK<\/p>\n\n\n\n<p><strong>Ken Farrington<\/strong>, Renal Medicine, East &amp; North Hertfordshire NHS Trust, Hertfordshire, UK<\/p>\n\n\n\n<p><strong>Indranil Dasgupta<\/strong>, Renal Medicine, Heart of England NHS Foundation Trust, Birmingham, UK<\/p>\n\n\n\n<p><strong>Lazaros Andronis<\/strong>, Health Economics Unit, University of Birmingham, Birmingham, UK<\/p>\n\n\n\n<p><strong><em>Publications:<\/em><\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/bmcnephrol.biomedcentral.com\/articles\/10.1186\/s12882-017-0554-1\">Davies, S. J., Caskey, F. J., Coyle, D., Lindley, E., Macdonald, J., Mitra, S., Wilkie, M., Davenport, A., Farrington, K., Dasgupta, I., Ormandy, P., Andronis, L., Solis-Trapala, I., &amp; Sim, J. (2017).&nbsp;Rationale and design of BISTRO: a randomized controlled trial to determine whether bioimpedance spectroscopy-guided fluid management maintains residual kidney function in incident haemodialysis patients.&nbsp;<em>BMC Nephrology<\/em>,&nbsp;<em>18<\/em>(1), 138.&nbsp;https:\/\/doi.org\/10.1186\/s12882-017-0554-1<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Background Preserved Residual Kidney Function (RKF) and normal fluid status are associated with better patient outcomes in incident haemodialysis patients. The objective of this trial is to determine whether using bioimpedance technology in prescribing the optimal post-dialysis weight can reduce the rate of decline of RKF and potentially improve patient outcomes. Professor Paula Ormandy from [&hellip;]<\/p>\n","protected":false},"author":421,"featured_media":0,"parent":60,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-2082","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>BioImpedance Spectroscopy to Maintain Renal Output: The BISTRO Trial - Centre for Applied Health Research<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/hub.salford.ac.uk\/applied-health-research\/long-term-conditions\/the-bistro-trial\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BioImpedance Spectroscopy to Maintain Renal Output: The BISTRO Trial - Centre for Applied Health Research\" \/>\n<meta property=\"og:description\" content=\"Background Preserved Residual Kidney Function (RKF) and normal fluid status are associated with better patient outcomes in incident haemodialysis patients. The objective of this trial is to determine whether using bioimpedance technology in prescribing the optimal post-dialysis weight can reduce the rate of decline of RKF and potentially improve patient outcomes. 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