Clinical trial NCT02276690: Hepcidine and Iron Deficiency in Critically Ill Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Critical Illness
Hospitalized for 5 Days or More
Keywords: iron deficiency
dosage of hepcidin
usual biomarker (ferritin and transferrin saturation)
mass spectrometry
immuno-detection
anaemia in intensive care unit
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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....).

Primary outcomes:
measure: Hospital cost
timeFrame: from Intensive Care Unit discharge to 90 days after (D90)
Secondary outcomes:
measure: Lenght of hospital stay post-Intensive Care Unit
timeFrame: until day 90 after Intensive Care Unit discharge
measure: Haemoglobin levels
timeFrame: 15 days post-Intensive Care Unit discharge
measure: Iron deficiency prevalence
timeFrame: at Day 15 after Intensive Care Unit discharge
measure: Fatigue
timeFrame: 30 days after Intensive Care Unit discharge
measure: Proportion of patient alive
timeFrame: at Day 90 after Intensive Care Unit discharge
measure: Proportion of patient at home
timeFrame: at Day 90 after Intensive Care Unit discharge
measure: Comparison between mass spectrometry and immuno-detection methods for hepcidin quantification (ancillary study)
timeFrame: from inclusion to Day15 after Intensive Care Unit discharge
Other outcomes:
Locations:
city: Angers
country: France
facility: Department of Anesthesiology & Critical Care, Angers University Hospital, 4 rue larrey
Study officials:
affiliation: Department of Anesthesiology & Critical Care, Angers University Hospital, France
name: Sigismond SL LASOCKI, PU-PH
role: STUDY_DIRECTOR
affiliation: Biochemistry and clinical proteomic laboratory, IRMB, St Eloi University Hospital
name: Sylvain SL LEHMANN, PU-PH
role: STUDY_CHAIR
References:
citation: 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 Dec;36(6):391-396. doi: 10.1016/j.accpm.2017.04.009. Epub 2017 Sep 14.
citation: Lasocki S, Asfar P, Jaber S, Ferrandiere M, Kerforne T, Asehnoune K, Montravers P, Seguin P, Peoc'h K, Gergaud S, Nagot N, Lefebvre T, Lehmann S; Hepcidane study group. Impact of treating iron deficiency, diagnosed according to hepcidin quantification, on outcomes after a prolonged ICU stay compared to standard care: a multicenter, randomized, single-blinded trial. Crit Care. 2021 Feb 15;25(1):62. doi: 10.1186/s13054-020-03430-3.