Intravenous iron or placebo for anaemia in intensive care: the IRONMAN multicentre randomized blinded trial : A randomized trial of IV iron in critical illness.
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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. The trial was registered at http://www.anzctr.org.au as # ACTRN12612001249842.
Intensive Care Unit, Fiona Stanley Hospital, Perth, WA, 6150, Australia. ed.litton@health.wa.gov.au.|School of Medicine and Pharmacology, University of Western Australia, Perth, WA, 6009, Australia. ed.litton@health.wa.gov.au.
Edward
E
Litton
Intensive Care Unit, Sir Charles Gardner Hospital, Perth, WA, 6009, Australia.
Stuart
S
Baker
School of Pathology and Laboratory Medicine, University of Australia, Perth, WA, 6009, Australia.
Wendy N
WN
Erber
Center for Population Health Research, Curtin University, Perth, WA, 6102, Australia.|CTEC School of Surgery, Faculty of Medicine Dentistry and Health Sciences, The University of Western Australia, Perth, WA, Australia.
Shannon
S
Farmer
Intensive Care Unit, Fiona Stanley Hospital, Perth, WA, 6150, Australia.
Janet
J
Ferrier
Western Health, Melbourne, VIC, Australia.|University of Melbourne, Melbourne, VIC, Australia.
Craig
C
French
Separation Science and Metabolomics Laboratory, Murdoch University, Perth, WA, Australia.
Joel
J
Gummer
Intensive Care Unit, Joondalup Health Campus, Perth, WA, Australia.
David
D
Hawkins
Centre of Research Excellence for Patient Blood Management in Critical Illness and Trauma, Monash University, Melbourne, VIC, Australia.
Alisa
A
Higgins
Center for Population Health Research, Curtin University, Perth, WA, 6102, Australia.|Institute of Anaesthesiology, University Hospital, Zurich, Switzerland.
Axel
A
Hofmann
Intensive Care Unit, Fiona Stanley Hospital, Perth, WA, 6150, Australia.
Bart
B
De Keulenaer
Intensive Care Unit, Royal Perth Hospital, Perth, WA, 6000, Australia.
Julie
J
McMorrow
Department of Gastroenterology, Fiona Stanley Hospital, Murdoch, WA, 6150, Australia.
John K
JK
Olynyk
University College London, London, UK.
Toby
T
Richards
Intensive Care Unit, Fiona Stanley Hospital, Perth, WA, 6150, Australia.
Simon
S
Towler
Separation Science and Metabolomics Laboratory, Murdoch University, Perth, WA, Australia.
Robert
R
Trengove
School of Medicine and Pharmacology, University of Western Australia, Perth, WA, 6009, Australia.|Intensive Care Unit, Royal Perth Hospital, Perth, WA, 6000, Australia.
Steve
S
Webb
D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D064591:Allografts; D000740:Anemia / Q000097:blood / Q000188:drug therapy*; D016001:Confidence Intervals; D016638:Critical Illness; D004311:Double-Blind Method; D017707:Erythrocyte Transfusion / Q000706:statistics & numerical data*; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D007362:Intensive Care Units; D057194:Intention to Treat Analysis; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008875:Middle Aged
D005290:Ferric Compounds; D006454:Hemoglobins; C522335:ferric carboxymaltose; D008320:Maltose
Allogeneic red blood cell transfusion; Anaemia; Critical care; IV iron
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