- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02276690
Hepcidine and Iron Deficiency in Critically Ill Patients (HEPCIDANE)
Medical Economic Analysis of the Interest of Hepcidin Quantitation by Quantitative Mass Spectrometry for the Diagnosis of Iron Deficiency in Anemic 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Angers, France, 49000
- Department of Anesthesiology & Critical Care, Angers University Hospital, 4 rue larrey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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….).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dosage of hepcidin
In order to assess iron deficiency, patients randomized in this arm will have dosage of hepcidin by mass spectrometry
|
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 |
Active Comparator: Usual biomarker dosage
In order to assess iron deficiency, patients randomized in this arm will have usual biomarker dosages (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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hospital cost
Time Frame: from Intensive Care Unit discharge to 90 days after (D90)
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from Intensive Care Unit discharge to 90 days after (D90)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lenght of hospital stay post-Intensive Care Unit
Time Frame: until day 90 after Intensive Care Unit discharge
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until day 90 after Intensive Care Unit discharge
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Haemoglobin levels
Time Frame: 15 days post-Intensive Care Unit discharge
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15 days post-Intensive Care Unit discharge
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Iron deficiency prevalence
Time Frame: at Day 15 after Intensive Care Unit discharge
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at Day 15 after Intensive Care Unit discharge
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Fatigue
Time Frame: 30 days after Intensive Care Unit discharge
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Fatigue will be assessed by the MFI-20 questionnaire
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30 days after Intensive Care Unit discharge
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Proportion of patient alive
Time Frame: at Day 90 after Intensive Care Unit discharge
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at Day 90 after Intensive Care Unit discharge
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Proportion of patient at home
Time Frame: at Day 90 after Intensive Care Unit discharge
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at Day 90 after Intensive Care Unit discharge
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Comparison between mass spectrometry and immuno-detection methods for hepcidin quantification (ancillary study)
Time Frame: from inclusion to Day15 after Intensive Care Unit discharge
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from inclusion to Day15 after Intensive Care Unit discharge
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sigismond SL LASOCKI, PU-PH, Department of Anesthesiology & Critical Care, Angers University Hospital, France
- Study Chair: Sylvain SL LEHMANN, PU-PH, Biochemistry and clinical proteomic laboratory, IRMB, St Eloi University Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9190
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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