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Completed

NCT Number: NCT02276690

Hepcidine and Iron Deficiency in Critically Ill Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology & Critical Care, Angers University Hospital, 4 rue larrey

Angers, 49000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Pregnancy
  • 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….).

Treatment and study plan

hepcidin

Biological

In order to assess iron deficiency by innovative method (dosage of Hepcidin), an additional collection of blood will be done at day 0 (and weekly until Intensive Care Unit discharge) and at Day 15 after Intensive Care Unit discharge.

Treatement of Iron deficiency anaemia and anaemia of chronic disease using intravenous iron (± erythropoietin) will be encouraged (or not) according to hepcidin levels

ferritin and transferrin saturation

Biological

In order to assess iron deficiency by using usual biomarkers (ferritin and transferrin saturation), collection of blood will be done at day 0 (and weekly until Intensive Care Unit discharge) and at Day 15 after Intensive Care Unit discharge.

Treatement of Iron deficiency anaemia and anaemia of chronic disease using intravenous iron (± erythropoietin) will be encouraged (or not) according to ferritin levels.

Primary outcomes

  1. Hospital cost

    Time frame: from Intensive Care Unit discharge to 90 days after (D90)

Secondary outcomes

  1. Lenght of hospital stay post-Intensive Care Unit

    Time frame: until day 90 after Intensive Care Unit discharge

  2. Haemoglobin levels

    Time frame: 15 days post-Intensive Care Unit discharge

  3. Iron deficiency prevalence

    Time frame: at Day 15 after Intensive Care Unit discharge

  4. Fatigue

    Time frame: 30 days after Intensive Care Unit discharge

    Fatigue will be assessed by the MFI-20 questionnaire

  5. Proportion of patient alive

    Time frame: at Day 90 after Intensive Care Unit discharge

  6. Proportion of patient at home

    Time frame: at Day 90 after Intensive Care Unit discharge

  7. Comparison between mass spectrometry and immuno-detection methods for hepcidin quantification (ancillary study)

    Time frame: from inclusion to Day15 after Intensive Care Unit discharge

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: HEPCIDANE

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Oct 28, 2014
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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