Intravenous iron or placebo for anaemia in intensive care: the IRONMAN multicentre randomized blinded trial

Intravenous iron or placebo for anaemia in intensive care: the IRONMAN multicentre randomized blinded trial
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DOI:
10.1007/s00134-016-4465-6
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发表时间:
2016-11-01
影响因子:
38.9
通讯作者:
Webb, Steve
Webb, Steve
中科院分区:
医学1区
文献类型:
--
作者:
Litton, Edward;Baker, Stuart;Webb, Steve

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贫血和同种异体红细胞输注在重症监护病房的患者中都很常见,并且可能有害。虽然静脉补铁可能会减少贫血和红细胞输血需求,但危重患者静脉补铁的安全性和有效性尚不确定。多中心、随机、安慰剂对照、盲法静脉补铁或安慰剂治疗重症监护贫血 (IRONMAN) 研究旨在检验以下假设:在入住重症监护病房的贫血危重患者中,与安慰剂相比,早期静脉补铁可减少住院期间的同种异体红细胞输注,出院时血红蛋白水平升高。在纳入的 140 名患者中,70 名接受静脉铁剂治疗,70 名接受安慰剂。铁剂组接受了 97 个红细胞单位,而安慰剂组则接受了 136 个红细胞单位,发生率比为 0.71 [95% 置信区间 (0.43-1.18),P = 0.19]。总体而言,静脉铁剂组出院时的中位血红蛋白显着高于安慰剂组[107(四分位比 IQR 97-115)vs. 100 g/L(IQR 89-111),P = 0.02]。各组之间在任何安全性结果上均无显着差异。在入住重症监护病房的贫血患者中,与安慰剂相比,静脉补铁并未导致住院期间红细胞输注需求显着降低。接受静脉铁剂治疗的患者出院时血红蛋白浓度显着升高。
Both anaemia and allogenic red blood cell transfusion are common and potentially harmful in patients admitted to the intensive care unit. Whilst intravenous iron may decrease anaemia and RBC transfusion requirement, the safety and efficacy of administering iron intravenously to critically ill patients is uncertain.The multicentre, randomized, placebo-controlled, blinded Intravenous Iron or Placebo for Anaemia in Intensive Care (IRONMAN) study was designed to test the hypothesis that, in anaemic critically ill patients admitted to the intensive care unit, early administration of intravenous iron, compared with placebo, reduces allogeneic red blood cell transfusion during hospital stay and increases the haemoglobin level at the time of hospital discharge.Of 140 patients enrolled, 70 were assigned to intravenous iron and 70 to placebo. The iron group received 97 red blood cell units versus 136 red blood cell units in the placebo group, yielding an incidence rate ratio of 0.71 [95 % confidence interval (0.43-1.18), P = 0.19]. Overall, median haemoglobin at hospital discharge was significantly higher in the intravenous iron group than in the placebo group [107 (interquartile ratio IQR 97-115) vs. 100 g/L (IQR 89-111), P = 0.02]. There was no significant difference between the groups in any safety outcome.In patients admitted to the intensive care unit who were anaemic, intravenous iron, compared with placebo, did not result in a significant lowering of red blood cell transfusion requirement during hospital stay. Patients who received intravenous iron had a significantly higher haemoglobin concentration at hospital discharge.