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Randomized Controlled Trial
Effect of intravenous iron on functional outcomes in hip fracture: a randomised controlled trial.
- Rafael Bielza, Jesús Llorente, Israel J Thuissard, Cristina Andreu-Vázquez, David Blanco, Jorge Sanjurjo, Néstor López, María Regina Herráez, Cristina Molano, Adoración Morales, Estefanía Arias, Marta Neira, Ana Lung, Javier Escalera, Laura Portillo, Yolanda Larrubia, Cristina García, Francisco Zambrana, and Jorge Gómez Cerezo.
- Department of Geriatric Medicine, Hospital Universitario Infanta Sofía (San Sebastián de los Reyes), Madrid, Spain.
- Age Ageing. 2021 Jan 8; 50 (1): 127-134.
Objectivesto determine the safety and effect of intravenous iron sucrose on functional outcomes, delirium, nosocomial infections and transfusion requirements in older patients with hip fracture.Designsingle-centre randomised, double-blind, placebo-controlled clinical trial.Setting And Participantsorthogeriatric share care service at an academic tertiary care hospital. A total of 253 patients were recruited: 126 patients were assigned to intravenous iron and 127 to placebo.Methodson days 1, 3 and 5 after admission, the iron group received 200 mg Venofer® (iron sucrose) in 100 ml saline and the placebo group 100 ml saline. The primary outcome was absolute functional gain, considered as Barthel index (BI) at discharge minus BI on admission. Secondary outcomes included incidence of postoperative delirium according to the confusion assessment method, proportion of patients recovering prior functional status at 3 months, postoperative transfusion requirements, haemoglobin at 3 months, incidence of nosocomial infections and safety.Resultsthe median participant age was 87 (interquartile range, 82.5-91.5) years. Most patients were female (72.7%), and the median previous BI was 81(59-95). No significant effect of intravenous iron was observed for the primary outcome: the median AFG score was 17.1 points (4.8-23.3) in the intravenous iron group and 16 points (6-26) in the placebo group (P = 0.369). No significant treatment effects were observed for other functional outcomes or secondary end points.Conclusionwhile we found no impact of intravenous iron sucrose on functional recovery, incidence of postoperative delirium, transfusion requirements, haemoglobin at 3 months, mortality and nosocomial infections rates in older patients with hip fracture, we did find that the intervention was safe.© The Author(s) 2020. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.
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