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Hepcidine and Iron Deficiency in Critically Ill Patients (HEPCIDANE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276690
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Anemia Critical Illness Hospitalized for 5 Days or More Biological: hepcidin Biological: ferritin and transferrin saturation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
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
Actual Study Start Date : August 2014
Actual Primary Completion Date : October 26, 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

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
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


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)
Biological: 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.





Primary Outcome Measures :
  1. Hospital cost [ Time Frame: from Intensive Care Unit discharge to 90 days after (D90) ]

Secondary Outcome Measures :
  1. Lenght of hospital stay post-Intensive Care Unit [ Time Frame: until day 90 after Intensive Care Unit discharge ]
  2. Haemoglobin levels [ Time Frame: 15 days post-Intensive Care Unit discharge ]
  3. Iron deficiency prevalence [ Time Frame: at Day 15 after Intensive Care Unit discharge ]
  4. Fatigue [ Time Frame: 30 days after Intensive Care Unit discharge ]
    Fatigue will be assessed by the MFI-20 questionnaire

  5. Proportion of patient alive [ Time Frame: at Day 90 after Intensive Care Unit discharge ]
  6. Proportion of patient at home [ Time Frame: at Day 90 after Intensive Care Unit discharge ]
  7. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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….).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276690


Locations
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France
Department of Anesthesiology & Critical Care, Angers University Hospital, 4 rue larrey
Angers, France, 49000
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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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:
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02276690    
Other Study ID Numbers: 9190
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: November 2015
Keywords provided by University Hospital, Montpellier:
iron deficiency
dosage of hepcidin
usual biomarker (ferritin and transferrin saturation)
mass spectrometry
immuno-detection
anaemia in intensive care unit
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Critical Illness
Anemia
Hematologic Diseases
Disease Attributes
Pathologic Processes
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Hepcidins
Anti-Infective Agents