{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T18:45:14Z","timestamp":1791830714498,"version":"4.3.4"},"reference-count":20,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"5","funder":[{"DOI":"10.13039\/501100000291","name":"Kidney Research UK","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000291","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Vifor Fresenius Medical Care Renal Pharma Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JASN"],"published-print":{"date-parts":[[2020,5]]},"abstract":"\n Significance Statement<\/jats:title>\n Experimental and observational data have raised concerns that intravenous (IV) iron might increase the risk of infections. In this analysis from the Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial involving 2141 patients on hemodialysis randomly assigned to receive either a high-dose or low-dose IV iron regimen, investigators reported finding no evidence that the two groups differed in incidence of infection, hospitalization for infection, or death from infection. Given the potential cardiovascular benefits of higher-dose IV iron seen in the PIVOTAL trial (due to either a direct effect of the IV iron or a decreased use of erythropoiesis-stimulating agents and thus, less exposure to associated cardiotoxic effects), this analysis provides reassurance for administering higher doses of IV iron than are currently given in many units worldwide.<\/jats:p>\n <\/jats:sec>\n \n Background<\/jats:title>\n Experimental and observational studies have raised concerns that giving intravenous (IV) iron to patients, such as individuals receiving maintenance hemodialysis, might increase the risk of infections. The Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial randomized 2141 patients undergoing maintenance hemodialysis for ESKD to a high-dose or a low-dose IV iron regimen, with a primary composite outcome of all-cause death, heart attack, stroke, or hospitalization for heart failure. Comparison of infection rates between the two groups was a prespecified secondary analysis.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Secondary end points included any infection, hospitalization for infection, and death from infection; we calculated cumulative event rates for these end points. We also interrogated the interaction between iron dose and vascular access (fistula versus catheter).<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n We found no significant difference between the high-dose IV iron group compared with the lose-dose group in event rates for all infections (46.5% versus 45.5%, respectively, which represented incidences of 63.3 versus 69.4 per 100 patient years, respectively); rates of hospitalization for infection (29.6% versus 29.3%, respectively) also did not differ. We did find a significant association between risk of a first cardiovascular event and any infection in the previous 30 days. Compared with patients undergoing dialysis with an arteriovenous fistula, those doing so\n via<\/jats:italic>\n a catheter had a higher incidence of having any infection, hospitalization for infection, or fatal infection, but IV iron dosing had no effect on these outcomes.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The high-dose and low-dose IV iron groups exhibited identical infection rates. Risk of a first cardiovascular event strongly associated with a recent infection.<\/jats:p>\n <\/jats:sec>","DOI":"10.1681\/asn.2019090972","type":"journal-article","created":{"date-parts":[[2020,4,6]],"date-time":"2020-04-06T17:16:01Z","timestamp":1586193361000},"page":"1118-1127","source":"Crossref","is-referenced-by-count":77,"title":["Intravenous Iron Dosing and Infection Risk in Patients on Hemodialysis: A Prespecified Secondary Analysis of the PIVOTAL Trial"],"prefix":"10.1681","volume":"31","author":[{"given":"Iain C.","family":"Macdougall","sequence":"first","affiliation":[{"name":"Department of Renal Medicine, King's College Hospital, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunil","family":"Bhandari","sequence":"additional","affiliation":[{"name":"Hull University Teaching Hospitals NHS Trust and Hull York Medical School, Hull, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"White","sequence":"additional","affiliation":[{"name":"Department of Renal Medicine, King's College Hospital, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan D.","family":"Anker","sequence":"additional","affiliation":[{"name":"Division of Cardiology and Metabolism, Department of Cardiology, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"},{"name":"Berlin-Brandenburg Center for Regenerative Therapies, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"},{"name":"German Centre for Cardiovascular Research Partner Site Berlin, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Farrington","sequence":"additional","affiliation":[{"name":"Lister Hospital, Stevenage, United Kingdom"},{"name":"University of Hertfordshire, Hertfordshire, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip A.","family":"Kalra","sequence":"additional","affiliation":[{"name":"Salford Royal Hospital, Salford, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3387-2123","authenticated-orcid":false,"given":"Patrick B.","family":"Mark","sequence":"additional","affiliation":[{"name":"British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6317-3975","authenticated-orcid":false,"given":"John J. V.","family":"McMurray","sequence":"additional","affiliation":[{"name":"British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chante","family":"Reid","sequence":"additional","affiliation":[{"name":"Department of Renal Medicine, King's College Hospital, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Robertson","sequence":"additional","affiliation":[{"name":"Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0224-8726","authenticated-orcid":false,"given":"Charles R.V.","family":"Tomson","sequence":"additional","affiliation":[{"name":"Freeman Hospital, Newcastle upon Tyne, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David C.","family":"Wheeler","sequence":"additional","affiliation":[{"name":"University College London, London, United Kingdom"},{"name":"George Institute for Global Health, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher G.","family":"Winearls","sequence":"additional","affiliation":[{"name":"Oxford Kidney Unit, The Churchill, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5927-1823","authenticated-orcid":false,"given":"Ian","family":"Ford","sequence":"additional","affiliation":[{"name":"Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the PIVOTAL Investigators and 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