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Litton e et al: Intravenous iron or placebo for anemia in intensive care: the IRONMAN multicenter randomized blinded trial.

Intensive Care Med 2016

The IRONMAN trial is a multicenter, placebo controlled, blinded and randomized protocol which treated 140 critically ill anemic patients. 70 patients were given 500 mg IV ferric carboxymaltose (FCM) /day every 4 days while in the ICU and compared to 70 patients receiving a saline placebo. The IV iron group trended toward decreased transfusions (97 RBC units, IV iron group versus 136 RBC units, placebo, p=0.19) and demonstrated a significantly higher mean hemoglobin at hospital discharge (p=0.02). Importantly, the IV iron treatment showed no statistical difference in infection, infection associated with organ failure or bacteremia. No immediate drug related adverse events associated with IV iron were identified. This study represents an important extension of the Pieracci et al study which showed the safety of low dose IV iron therapy (100 mg thrice weekly) in ICU patients. IRONMAN demonstrates that a larger same day dose of 500 mg can be safely given to critically ill patients without an increased risk of infection or adverse drug effects. The lack of a statistically significant reduction in RBC transfusion may in part be due to the studies protocol of treating all anemic patients with IV iron instead of identifying and treating only those patients with iron deficiency anemia. Similarly, most patients received a single dose of 500 mg FCM which undertreats the typical case of iron deficiency. The IRONMAN trial is an important addition to the growing body of literature documenting the safety of using IV iron to treat iron deficiency in the very ill.

Pieracci FM et al., A multicenter, randomized clinical trial of IV iron supplementation for anemia of traumatic critical illness. Crit Care Med 2014 42:2048–2057