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采用铁调素质谱测定法诊断缺铁对 ICU 长时间住院患者住院时间和费用的影响:一项多中心、随机、单盲医学经济学试验的研究方案。

Impact of iron deficiency diagnosis using hepcidin mass spectrometry dosage methods on hospital stay and costs after a prolonged ICU stay: Study protocol for a multicentre, randomised, single-blinded medico-economic trial.

机构信息

Département anesthésie réanimation, Institut MITOVASC, CNRS UMR 6214, Inserm U1083, Université d'Angers, CHU d'Angers, 4, rue Larrey, 49933 Angers cedex 9, France.

Université Paris-Diderot, Sorbonne-Paris-Cité, Paris, France; Inserm U1149, centre de recherche sur l'inflammation, France; Laboratory of excellence, GR-Ex, Paris, France; Hôpital Louis-Mourier, centre français des porphyries, AP-HP, Colombes, France.

出版信息

Anaesth Crit Care Pain Med. 2017 Dec;36(6):391-396. doi: 10.1016/j.accpm.2017.04.009. Epub 2017 Sep 14.

Abstract

BACKGROUND

Iron deficiency (ID) is frequent but difficult to diagnose in critically ill patients. ID may be responsible for prolonged post-ICU hospital stays, since it results in fatigue, muscle weakness and anaemia. Hepcidin, the key iron metabolism hormone, may be a good marker of ID in these patients. The aim of this study is to determine whether using mass spectrometry hepcidin determination to diagnose (and treat) ID after prolonged ICU stays may reduce patients' subsequent hospital stays and costs in comparison with conventional (ferritin) methods.

METHODS

This is a randomised, controlled, single-blinded, multicentre medico-economic study. Hepcidin quantification will be performed in anaemic (WHO criteria) critically ill adults about to be discharged, after a stay ≥5days. In the intervention arm (hepcidin) results will be given to the ICU-physicians, and not in the control arm. ID Treatment will be recommended in intervention arm: IV iron when hepcidin is <20μg/L; IV iron+erythropoietin when hepcidin is between 20-41μg/L; in the control arm: IV iron when ferritin <300μg/L and Transferrin saturation <20%. The primary endpoint will be the number of days spent in hospital 90 days after ICU discharge and the direct hospital costs. Secondary endpoints will be anaemia and iron deficiency on D15, fatigue and the proportion of patients alive and at home on D30 and D90.

DISCUSSION

The results of this study will show whether diagnosing iron deficiency using MS hepcidin determination methods is liable to reduce patients' post-ICU hospital stay and costs, as well as their anaemia and fatigue.

摘要

背景

铁缺乏症(ID)在危重症患者中很常见,但难以诊断。ID 可能导致 ICU 后住院时间延长,因为它会导致疲劳、肌肉无力和贫血。铁调素是关键的铁代谢激素,可能是这些患者 ID 的良好标志物。本研究的目的是确定在 ICU 长时间停留后使用质谱法铁调素测定来诊断(和治疗) ID 是否可以降低患者随后的住院时间和费用,与传统(铁蛋白)方法相比。

方法

这是一项随机、对照、单盲、多中心的医学经济学研究。在即将出院的贫血(WHO 标准)危重症成年人中,在停留≥5 天后,进行铁调素定量测定。在干预组(铁调素)中,将向 ICU 医生提供结果,而在对照组中则不提供。在干预组中,建议进行 ID 治疗:当铁调素<20μg/L 时给予静脉铁;当铁调素在 20-41μg/L 之间时给予静脉铁+促红细胞生成素;在对照组中,当铁蛋白<300μg/L 且转铁蛋白饱和度<20%时给予静脉铁。主要终点是 ICU 出院后 90 天内住院天数和直接住院费用。次要终点是 D15 时的贫血和缺铁、疲劳以及 D30 和 D90 时存活和在家的患者比例。

讨论

该研究的结果将表明,使用 MS 铁调素测定方法诊断铁缺乏症是否会缩短患者 ICU 后的住院时间和费用,以及他们的贫血和疲劳。

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