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根据铁调素定量诊断缺铁后进行治疗对延长 ICU 住院时间患者结局的影响：一项多中心、随机、单盲试验。

Impact of treating iron deficiency, diagnosed according to hepcidin quantification, on outcomes after a prolonged ICU stay compared to standard care: a multicenter, randomized, single-blinded trial.

机构信息

Département Anesthésie Réanimation, CHU Angers, Université D'Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.

Département Médecine Intensive Réanimation, CHU Angers, Université D'Angers, Angers, France.

出版信息

Crit Care. 2021 Feb 15;25(1):62. doi: 10.1186/s13054-020-03430-3.

DOI:10.1186/s13054-020-03430-3

PMID:33588893

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7885380/

Abstract

BACKGROUND

Anemia is a significant problem in patients on ICU. Its commonest cause, iron deficiency (ID), is difficult to diagnose in the context of inflammation. Hepcidin is a new marker of ID. We aimed to assess whether hepcidin levels would accurately guide treatment of ID in critically ill anemic patients after a prolonged ICU stay and affect the post-ICU outcomes.

METHODS

In a controlled, single-blinded, multicenter study, anemic (WHO definition) critically ill patients with an ICU stay ≥ 5 days were randomized when discharge was expected to either intervention by hepcidin treatment protocol or control. In the intervention arm, patients were treated with intravenous iron (1 g of ferric carboxymaltose) when hepcidin was < 20 μg/l and with intravenous iron and erythropoietin for 20 ≤ hepcidin < 41 μg/l. Control patients were treated according to standard care (hepcidin quantification remained blinded). Primary endpoint was the number of days spent in hospital 90 days after ICU discharge (post-ICU LOS). Secondary endpoints were day 15 anemia, day 30 fatigue, day 90 mortality and 1-year survival.

RESULTS

Of 405 randomized patients, 399 were analyzed (201 in intervention and 198 in control arm). A total of 220 patients (55%) had ID at discharge (i.e., a hepcidin < 41 μg/l). Primary endpoint was not different (medians (IQR) post-ICU LOS 33(13;90) vs. 33(11;90) days for intervention and control, respectively, median difference - 1(- 3;1) days, p = 0.78). D90 mortality was significantly lower in intervention arm (16(8%) vs 33(16.6%) deaths, absolute risk difference - 8.7 (- 15.1 to - 2.3)%, p = 0.008, OR 95% IC, 0.46, 0.22-0.94, p = 0.035), and one-year survival was improved (p = 0.04).

CONCLUSION

Treatment of ID diagnosed according to hepcidin levels did not reduce the post-ICU LOS, but was associated with a significant reduction in D90 mortality and with improved 1-year survival in critically ill patients about to be discharged after a prolonged stay.

TRIAL REGISTRATION

www.clinicaltrial.gov NCT02276690 (October 28, 2014; retrospectively registered).

摘要

背景

贫血是 ICU 患者的一个严重问题。其最常见的原因是铁缺乏症（ID），而在炎症的情况下，ID 很难被诊断。铁调素是 ID 的一个新标志物。我们旨在评估铁调素水平是否能准确指导长期 ICU 住院后贫血危重病患者的 ID 治疗，并影响 ICU 后的结果。

方法

在一项对照、单盲、多中心研究中，当预计患者将出院时，将 ICU 住院时间≥5 天的贫血（世界卫生组织定义）危重病患者随机分配至接受铁调素治疗方案干预或对照组。在干预组中，当铁调素<20μg/l 时，给予患者静脉注射铁（1g 羧基麦芽糖铁），当 20≤铁调素<41μg/l 时，给予患者静脉注射铁和促红细胞生成素。对照组患者根据标准治疗进行治疗（铁调素定量仍保持盲法）。主要终点是 ICU 出院后 90 天的住院天数（ICU 后 LOS）。次要终点是第 15 天贫血、第 30 天疲劳、第 90 天死亡率和 1 年生存率。

结果

在 405 名随机患者中，对 399 名患者进行了分析（干预组 201 名，对照组 198 名）。共有 220 名患者（55%）在出院时存在 ID（即铁调素<41μg/l）。主要终点没有差异（干预组和对照组 ICU 后 LOS 的中位数（IQR）分别为 33（13；90）和 33（11；90）天，中位数差值-1（-3；1）天，p=0.78）。干预组第 90 天死亡率显著降低（16（8%）vs. 33（16.6%）死亡，绝对风险差异-8.7（-15.1 至-2.3）%，p=0.008，OR 95%CI，0.46，0.22-0.94，p=0.035），1 年生存率提高（p=0.04）。