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临床试验/NCT02276690
NCT02276690已完成不适用

Medical Economic Analysis of the Interest of Hepcidin Quantitation by Quantitative Mass Spectrometry for the Diagnosis of Iron Deficiency in Anemic Critically Ill Patients

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 408 人开始时间: 2014年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
408
试验地点
1
主要终点
Hospital cost

研究概览

简要总结

Anaemia is very frequent among critically ill patients, concerning more than 60 % of them at admission and more than 80% at intensive care unit discharge. Iron deficiency is also frequent at admission, with prevalence around 25 to 40%. During their stay in Intensive Care Unit, critically ill patients are exposed to repeated blood samples and to other blood losses (daily blood loss has been evaluated to be as high as 128 ml/day in median), this leads to direct iron loss. Prevalence of iron deficiency may thus be very important at Intensive Care Unit discharge. However, iron deficiency diagnosis is complicated in these patients, since inflammation induces an increase in plasma ferritin levels and a decrease in transferrin saturation, the two usual markers of iron deficiency. As a consequence, iron deficiency is usely under-diagnosed in these patients. Treatment of iron deficiency may be indicated to correct anaemia but also to improve patients fatigue and muscular weakness. The characterization of iron metabolism regulation by the hormone hepcidin opened new ways for the understanding and the follow-up of these complex clinical situations (combining inflammation and iron deficiency). Indeed, iron deficiency is associated with a decrease in hepcidin synthesis, while iron overload induces hepcidin synthesis. Furthermore, low hepcidin levels are required to mobilize iron from stores. Hepcidin has thus be proposed as a marker of iron deficiency in critically ill patients. To date, standard immunological methods of hepcidin quantitation are only proposed in the reasearch setting and could not be proposed in the clinical setting because it is too expensive. New approaches for hepcidin quantification, based on mass spectrometry are proposed and may be routinely implemented. We make the hypothesis that treating iron deficiency in critically ill anemic patients, diagnosed by hepcidin quantification, may improve the post-Intensive Care Unit rehabilitation, and may thus reduce post-Intensive Care Unit cost linked to hospital stay and anaemia treatment.

The aim of this study is to evaluate the medical economic interest of a new diagnostic method for iron deficiency, based on a quantitative dosage of hepcidin by mass spectrometry in critically ill anaemic patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Hospitalized man/woman in reanimation unit for at least 5 days.
  • •Age ≥ 18 years old.
  • •Patient having an anaemia such as defined by the WHO (World Health Organization) (for man: Hemoglobin < 13 g/dl, for woman: Hemoglobin < 12 g/dl).
  • •Signed inform consent by the patient or a close person.
  • •Subject affiliated to a national health insurance

排除标准

  • •Known iron metabolism pathology (such as primitive or secondary hemochromatosis, ...).
  • •Chronic anaemia (Hemoglobin ≤ 10 g/dl for more than 3 months).
  • •Current chemotherapy.
  • •Patient having an organ transplant
  • •Expected survival < 28 days post Intensive Care Unit discharge.
  • •Patient deprived of freedom, by judicial or administrative order.
  • •Major protected by the law.
  • •Contra-indication to the injectable iron treatment (allergy to ferric carboxymaltose, infection derivates (bacteriamy < 48 hours) untreated).
  • •Non speaking French patient, or patient unable to answer a questionnaire because of any neurologic disorder (stroke, brain trauma....).

研究组 & 干预措施

Dosage of hepcidin

Experimental

In order to assess iron deficiency, patients randomized in this arm will have dosage of hepcidin by mass spectrometry

干预措施: hepcidin (Biological)

Usual biomarker dosage

Active Comparator

In order to assess iron deficiency, patients randomized in this arm will have usual biomarker dosages (ferritin and transferrin saturation)

干预措施: ferritin and transferrin saturation (Biological)

结局指标

主要结局

Hospital cost

时间窗: from Intensive Care Unit discharge to 90 days after (D90)

次要结局

  • Iron deficiency prevalence(at Day 15 after Intensive Care Unit discharge)
  • Comparison between mass spectrometry and immuno-detection methods for hepcidin quantification (ancillary study)(from inclusion to Day15 after Intensive Care Unit discharge)
  • Haemoglobin levels(15 days post-Intensive Care Unit discharge)
  • Lenght of hospital stay post-Intensive Care Unit(until day 90 after Intensive Care Unit discharge)
  • Fatigue(30 days after Intensive Care Unit discharge)
  • Proportion of patient alive(at Day 90 after Intensive Care Unit discharge)
  • Proportion of patient at home(at Day 90 after Intensive Care Unit discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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