Hepcidine and Iron Deficiency in Critically Ill Patients

Not Applicable

Completed

• Conditions: Critical Illness; Hospitalized for 5 Days or More; Anemia
• Interventions: Biological: hepcidin; Biological: ferritin and transferrin saturation

• Registration Number: NCT02276690
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-28
• Status Verified: 2015-11
• Primary Completion: 2016-10-26
• Study Completion: 2017-09
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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....).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dosage of hepcidin	hepcidin	In order to assess iron deficiency, patients randomized in this arm will have dosage of hepcidin by mass spectrometry
Usual biomarker dosage	ferritin and transferrin saturation	In order to assess iron deficiency, patients randomized in this arm will have usual biomarker dosages (ferritin and transferrin saturation)

Primary Outcome Measures

Name	Time	Method
Hospital cost	from Intensive Care Unit discharge to 90 days after (D90)

Secondary Outcome Measures

Name	Time	Method
Haemoglobin levels	15 days post-Intensive Care Unit discharge
Iron deficiency prevalence	at Day 15 after 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	Fatigue will be assessed by the MFI-20 questionnaire
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
Comparison between mass spectrometry and immuno-detection methods for hepcidin quantification (ancillary study)	from inclusion to Day15 after Intensive Care Unit discharge

Trial Locations

Locations (1)

Department of Anesthesiology & Critical Care, Angers University Hospital, 4 rue larrey; 🇫🇷 Angers, France