Hepcidine and Iron Deficiency in Critically Ill Patients (HEPCIDANE)
Primary Purpose
Anemia, Critical Illness, Hospitalized for 5 Days or More
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hepcidin
ferritin and transferrin saturation
Sponsored by
About this trial
This is an interventional diagnostic trial for Anemia focused on measuring iron deficiency, dosage of hepcidin, usual biomarker (ferritin and transferrin saturation), mass spectrometry, immuno-detection, anaemia in intensive care unit
Eligibility Criteria
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….).
Sites / Locations
- Department of Anesthesiology & Critical Care, Angers University Hospital, 4 rue larrey
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dosage of hepcidin
Usual biomarker dosage
Arm Description
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, patients randomized in this arm will have usual biomarker dosages (ferritin and transferrin saturation)
Outcomes
Primary Outcome Measures
Hospital cost
Secondary Outcome Measures
Lenght of hospital stay post-Intensive Care Unit
Haemoglobin levels
Iron deficiency prevalence
Fatigue
Fatigue will be assessed by the MFI-20 questionnaire
Proportion of patient alive
Proportion of patient at home
Comparison between mass spectrometry and immuno-detection methods for hepcidin quantification (ancillary study)
Full Information
NCT ID
NCT02276690
First Posted
October 16, 2014
Last Updated
October 5, 2017
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02276690
Brief Title
Hepcidine and Iron Deficiency in Critically Ill Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
October 26, 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
408 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dosage of hepcidin
Arm Type
Experimental
Arm Description
In order to assess iron deficiency, patients randomized in this arm will have dosage of hepcidin by mass spectrometry
Arm Title
Usual biomarker dosage
Arm Type
Active Comparator
Arm Description
In order to assess iron deficiency, patients randomized in this arm will have usual biomarker dosages (ferritin and transferrin saturation)
Intervention Type
Biological
Intervention Name(s)
hepcidin
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
ferritin and transferrin saturation
Intervention Description
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 Measure Information:
Title
Hospital cost
Time Frame
from Intensive Care Unit discharge to 90 days after (D90)
Secondary Outcome Measure Information:
Title
Lenght of hospital stay post-Intensive Care Unit
Time Frame
until day 90 after Intensive Care Unit discharge
Title
Haemoglobin levels
Time Frame
15 days post-Intensive Care Unit discharge
Title
Iron deficiency prevalence
Time Frame
at Day 15 after Intensive Care Unit discharge
Title
Fatigue
Description
Fatigue will be assessed by the MFI-20 questionnaire
Time Frame
30 days after Intensive Care Unit discharge
Title
Proportion of patient alive
Time Frame
at Day 90 after Intensive Care Unit discharge
Title
Proportion of patient at home
Time Frame
at Day 90 after Intensive Care Unit discharge
Title
Comparison between mass spectrometry and immuno-detection methods for hepcidin quantification (ancillary study)
Time Frame
from inclusion to Day15 after Intensive Care Unit discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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….).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigismond SL LASOCKI, PU-PH
Organizational Affiliation
Department of Anesthesiology & Critical Care, Angers University Hospital, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sylvain SL LEHMANN, PU-PH
Organizational Affiliation
Biochemistry and clinical proteomic laboratory, IRMB, St Eloi University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology & Critical Care, Angers University Hospital, 4 rue larrey
City
Angers
ZIP/Postal Code
49000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28919067
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.
Results Reference
background
PubMed Identifier
33588893
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.
Results Reference
derived
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Hepcidine and Iron Deficiency in Critically Ill Patients
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