Intravenous iron to treat anaemia following critical care: a multicentre feasibility randomised trial,British Journal of Anaesthesia

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Intravenous iron to treat anaemia following critical care: a multicentre feasibility randomised trial
British Journal of Anaesthesia ( IF 9.8 ) Pub Date : 2021-12-03 , DOI: 10.1016/j.bja.2021.11.010
Akshay Shah ₁ , Mae Chester-Jones ₂ , Susan J Dutton ₂ , Ioana R Marian ₂ , Vicki S Barber ₂ , David M Griffith ₃ , Jo Singleton ₄ , Katherine Wray ₅ , Tim James ₆ , Hal Drakesmith ₇ , Peter A Robbins ₈ , Matthew C Frise ₉ , J Duncan Young ₁₀ , Timothy S Walsh ₁₁ , Stuart R McKechnie ₁₂ , Simon J Stanworth ₁₃ ,

Affiliation

Radcliffe Department of Medicine, University of Oxford, Oxford, UK; Adult Intensive Care Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, 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.

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).

中文翻译：

静脉铁剂治疗重症监护后贫血：一项多中心可行性随机试验

背景

贫血很常见，并且与危重病幸存者的不良预后有关。然而，最佳治疗策略尚不清楚。

方法

我们进行了一项多中心、可行性 RCT，以比较单剂量 1000 mg iv 羧基麦芽糖铁或常规治疗对从 ICU 出院的中度或重度贫血（血红蛋白 ≤100 g L ^-1）患者的疗效。我们收集了有关可行性（招募、随机化、随访）、生物学疗效和临床结果的数据。

结果

98 名参与者被随机分配（每组 49 名）。总体招募率为 34%，平均每月招募 6.5 名参与者。49 名参与者中有 47 名 (96%) 接受了干预。90 天时，79/93 (85%) 名幸存者可获得患者报告的结果测量值。在 28 天（119.8 [13.3] vs 106.7 [14.9] g L ^-1）和 90 天（130.5 [15.1] vs 122.7 [17.3] g L ^-1时，静脉补铁导致更高的平均血红蛋白（标准差 [ sd ]） )，调整后的平均差（10.98 g L ^-1；95% 置信区间 [CI]，4.96–17.01；P<0.001) 随机化后 90 天。两组的感染率相似。静脉铁剂组出院后 90 天的再入院率较低（7/40 vs 15/39；风险比=0.46；95% CI，0.21-0.99；P = 0.037）。静脉铁剂组的中位（四分位间距）ICU 住院时间较短，但未达到统计学意义（5.0 [3.0-13.0] vs 9.0 [5.0-16.0] 天，P = 0.15）。