Hepcidine and Iron Deficiency in Critically Ill Patients

Anemia Clinical Trial

— HEPCIDANE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276690
• Other study ID #: 9190
• Status: Completed
• Phase: N/A
• First received: October 16, 2014
• Last updated: October 5, 2017
• Start date: August 2014
• Est. completion date: September 2017

Study information

• Verified date: November 2015
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: September 2017
• Est. primary completion date: October 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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….).

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Critical Illness
• Hospitalized for 5 Days or More

Intervention

Biological:
• hepcidin
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
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.

Locations

Country	Name	City	State
France	Department of Anesthesiology & Critical Care, Angers University Hospital, 4 rue larrey	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

Lasocki S, Puy H, Mercier G, Lehmann S; Hepcidane study group. 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. Anaesth Crit Care Pain Med. 2017 Sep 14. pii: S2352-5568(17)30089-9. doi: 10.1016/j.accpm.2017.04.009. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital cost		from Intensive Care Unit discharge to 90 days after (D90)
Secondary	Lenght of hospital stay post-Intensive Care Unit		until day 90 after Intensive Care Unit discharge
Secondary	Haemoglobin levels		15 days post-Intensive Care Unit discharge
Secondary	Iron deficiency prevalence		at Day 15 after Intensive Care Unit discharge
Secondary	Fatigue	Fatigue will be assessed by the MFI-20 questionnaire	30 days after Intensive Care Unit discharge
Secondary	Proportion of patient alive		at Day 90 after Intensive Care Unit discharge
Secondary	Proportion of patient at home		at Day 90 after Intensive Care Unit discharge
Secondary	Comparison between mass spectrometry and immuno-detection methods for hepcidin quantification (ancillary study)		from inclusion to Day15 after Intensive Care Unit discharge