Anemia, Critical Illness, Hospitalized for 5 Days or More
Conditions
Keywords
iron deficiency, dosage of hepcidin, usual biomarker (ferritin and transferrin saturation), mass spectrometry, immuno-detection, anaemia in intensive care unit
Brief summary
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.
Interventions
BIOLOGICALhepcidin
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
BIOLOGICALferritin and transferrin saturation
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.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hospitalized man/woman in reanimation unit for at least 5 days. 2. Age ≥ 18 years old. 3. 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). 4. Signed inform consent by the patient or a close person. 5. Subject affiliated to a national health insurance
Exclusion criteria
1. Known iron metabolism pathology (such as primitive or secondary hemochromatosis, …). 2. Chronic anaemia (Hemoglobin ≤ 10 g/dl for more than 3 months). 3. Current chemotherapy. 4. Patient having an organ transplant 5. Expected survival \< 28 days post Intensive Care Unit discharge. 6. Pregnancy 7. Patient deprived of freedom, by judicial or administrative order. 8. Major protected by the law. 9. Contra-indication to the injectable iron treatment (allergy to ferric carboxymaltose, infection derivates (bacteriamy \< 48 hours) untreated). 10. Non speaking French patient, or patient unable to answer a questionnaire because of any neurologic disorder (stroke, brain trauma….).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital cost | from Intensive Care Unit discharge to 90 days after (D90) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 30 days after Intensive Care Unit discharge | Fatigue will be assessed by the MFI-20 questionnaire |
| Proportion of patient alive | at Day 90 after Intensive Care Unit discharge | — |
| Lenght of hospital stay post-Intensive Care Unit | until day 90 after Intensive Care Unit discharge | — |
| Proportion of patient at home | at Day 90 after Intensive Care Unit discharge | — |
| 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 | — |
Countries
France
Outcome results
None listed