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Intravenous iron to treat anaemia following critical care: a multicentre feasibility randomised trial

Radcliffe Department of Medicine, University of Oxford, Oxford, UK; Adult Intensive Care Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK. Electronic address: akshay.shah@linacre.ox.ac.uk. Oxford Clinical Trials Research Unit (OCTRU), Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Anaesthesia, Critical Care and Pain Medicine, University of Edinburgh, Edinburgh, UK; Deanery of Molecular, Genetic and Population Health Sciences and University of Edinburgh, Edinburgh, UK. Anaesthesia, Critical Care and Pain Medicine, University of Edinburgh, Edinburgh, UK. MRC Human Immunology Unit, MRC Weatherall Institute of Molecular Medicine, Oxford, UK. Department of Clinical Biochemistry, Oxford University Hospitals NHS Foundation Trust, Oxford, UK. MRC Human Immunology Unit, MRC Weatherall Institute of Molecular Medicine, Oxford, UK; Haematology Theme, NIHR Oxford Biomedical Research Centre, Oxford, UK. Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK. Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK; Intensive Care Unit, Royal Berkshire Hospitals NHS Foundation Trust, Reading, UK. Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK. Anaesthesia, Critical Care and Pain Medicine, University of Edinburgh, Edinburgh, UK; Usher Institute for Population Health Sciences, University of Edinburgh, Edinburgh, UK. Adult Intensive Care Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Nuffield Department of Anaesthetics, Oxford University Hospitals NHS Foundation Trust, Oxford, UK. Radcliffe Department of Medicine, University of Oxford, Oxford, UK; Haematology Theme, NIHR Oxford Biomedical Research Centre, Oxford, UK; Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.

British journal of anaesthesia. 2021
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PICO Summary

Population

Patients being discharged from the intensive care unit (ICU) with moderate or severe anaemia (n= 98).

Intervention

Single dose of ferric carboxymaltose (n= 49).

Comparison

Usual care (n= 49).

Outcome

Patient-reported outcome measures were available for 85% survivors at 90 days. Intravenous iron resulted in a higher mean (standard deviation [sd]) haemoglobin at 28 days (119.8 [13.3] vs. 106.7 [14.9] g L(-1)) and 90 days (130.5 [15.1] vs. 122.7 [17.3] g L(-1)), adjusted mean difference (10.98 g L(-1)) over 90 days after randomisation. Infection rates were similar in both groups. Hospital readmissions at 90 days post-ICU discharge were lower in the intravenous iron group (7/40 vs. 15/39). The median (inter-quartile range) post-ICU hospital stay was shorter in the intravenous iron group but did not reach statistical significance (5.0 [3.0-13.0] vs. 9.0 [5.0-16.0]) days.
Abstract
BACKGROUND Anaemia is common and associated with poor outcomes in survivors of critical illness. However, the optimal treatment strategy is unclear. METHODS We conducted a multicentre, feasibility RCT to compare either a single dose of ferric carboxymaltose 1000 mg i.v. or usual care in patients being discharged from the ICU with moderate or severe anaemia (haemoglobin ≤100 g L(-1)). We collected data on feasibility (recruitment, randomisation, follow-up), biological efficacy, and clinical outcomes. RESULTS Ninety-eight participants were randomly allocated (49 in each arm). The overall recruitment rate was 34% with 6.5 participants recruited on average per month. Forty-seven of 49 (96%) participants received the intervention. Patient-reported outcome measures were available for 79/93 (85%) survivors at 90 days. Intravenous iron resulted in a higher mean (standard deviation [sd]) haemoglobin at 28 days (119.8 [13.3] vs 106.7 [14.9] g L(-1)) and 90 days (130.5 [15.1] vs 122.7 [17.3] g L(-1)), adjusted mean difference (10.98 g L(-1); 95% confidence interval [CI], 4.96-17.01; P<0.001) over 90 days after randomisation. Infection rates were similar in both groups. Hospital readmissions at 90 days post-ICU discharge were lower in the i.v. iron group (7/40 vs 15/39; risk ratio=0.46; 95% CI, 0.21-0.99; P=0.037). The median (inter-quartile range) post-ICU hospital stay was shorter in the i.v. iron group but did not reach statistical significance (5.0 [3.0-13.0] vs 9.0 [5.0-16.0] days, P=0.15). CONCLUSION A large, multicentre RCT of i.v. iron to treat anaemia in survivors of critical illness appears feasible and is necessary to determine the effects on patient-centred outcomes. CLINICAL TRIAL REGISTRATION ISRCTN13721808 (www.isrctn.com).
Study details
Language : eng
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