Effect of intravenous iron on functional outcomes in hip fracture: a randomised controlled trial

Abstract

Objectives to determine the safety and effect of intravenous iron sucrose on functional outcomes, delirium, nosocomial infections and transfusion requirements in older patients with hip fracture. Design single-centre randomised, double-blind, placebo-controlled clinical trial. Setting and participants orthogeriatric 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. Methods on 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. Results the 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. Conclusion while 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.

Risk of Infection Associated With Administration of Intravenous Iron

“…A total of 162 studies with 40 066 participants were included in this systematic review, of which 154 were RCTs (32 920 participants) and 8 were NRSs (7146 participants) . Two RCTs were analyzed as 2 separate studies each.…”

“…Seventy-four RCTs were multicenter, and studies were performed in a wide range of clinical settings (Table 1). The most common settings were obstetrics (39 RCTs; 9993 participants), surgery (27 RCTs; 4223 participants), and CKD (22 RCTs; 6013 participants) . Trials were conducted across all continents, with the most common location being Europe (n = 56) .…”

“…The most common settings were obstetrics (39 RCTs; 9993 participants), surgery (27 RCTs; 4223 participants), and CKD (22 RCTs; 6013 participants) . Trials were conducted across all continents, with the most common location being Europe (n = 56) . The most common iron preparations evaluated were iron sucrose (n = 68) and ferric carboxymaltose (n = 51) …”

“…Trials were conducted across all continents, with the most common location being Europe (n = 56) . The most common iron preparations evaluated were iron sucrose (n = 68) and ferric carboxymaltose (n = 51) …”

Study protocol for a multicentre, 2×2 factorial, randomised, controlled trial evaluating the interest of intravenous iron and tranexamic acid to reduce blood transfusion in hip fracture patients (the HiFIT study)

“…New iron formulations allowing to deliver high doses of iron in one short intravenous injection (as much as 20 mg/kg, maximum 2000 mg, over 30 min for iron isomaltoside (IIM)) are efficient to reduce postoperative anaemia when given on the day of surgery, 16 when smaller iron doses (ie, 600 mg) were ineffective in patients with HF. 17 In addition, iron deficiency is responsible for fatigue and muscular weakness, which may be corrected by intravenous iron. 18–22 This could be particularly important for this older population, for whom postoperative rehabilitation is of crucial importance.…”