AnemiaHEPCIDANENCT02276690
Hepcidine and Iron Deficiency in Critically Ill Patients
A study testing hepcidin and ferritin and transferrin saturation in people with Anemia and Critical Illness, run by University Hospital, Montpellier at 1 site in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Critical Illness, Hospitalized for 5 Days or More
- What is being tested?
- hepcidin and ferritin and transferrin saturation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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….).
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Anesthesiology & Critical Care, Angers University Hospital, 4 rue larrey
Angers, 49000
About this study
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
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.
- Conditions
- Anemia, Critical Illness, Hospitalized for 5 Days or More
- Being tested
- hepcidin, ferritin and transferrin saturation
- Keywords
- iron deficiency, dosage of hepcidin, usual biomarker (ferritin and transferrin saturation), mass spectrometry, immuno-detection, anaemia in intensive care unit
- Medical subject headings
- Anemia, Critical Illness, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepcidinBiological
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
ferritin and transferrin saturationBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Dosage of hepcidin | Experimental | In order to assess iron deficiency, patients randomized in this arm will have dosage of hepcidin by mass spectrometry Receives: Biological: hepcidin |
| Usual biomarker dosage | Active comparator | In order to assess iron deficiency, patients randomized in this arm will have usual biomarker dosages (ferritin and transferrin saturation) Receives: Biological: ferritin and transferrin saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital cost
Measured: from Intensive Care Unit discharge to 90 days after (D90)
Secondary outcomes (7)
Lenght of hospital stay post-Intensive Care Unit
Measured: until day 90 after Intensive Care Unit discharge
Haemoglobin levels
Measured: 15 days post-Intensive Care Unit discharge
Iron deficiency prevalence
Measured: at Day 15 after Intensive Care Unit discharge
Fatigue
Fatigue will be assessed by the MFI-20 questionnaire
Measured: 30 days after Intensive Care Unit discharge
Proportion of patient alive
Measured: at Day 90 after Intensive Care Unit discharge
Proportion of patient at home
Measured: at Day 90 after Intensive Care Unit discharge
Comparison between mass spectrometry and immuno-detection methods for hepcidin quantification (ancillary study)
Measured: from inclusion to Day15 after Intensive Care Unit discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startAug 2014
- Primary completion26 Oct 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sigismond SL LASOCKI, PU-PH, Study director, Department of Anesthesiology & Critical Care, Angers University Hospital, FranceSylvain SL LEHMANN, PU-PH, Study chair, Biochemistry and clinical proteomic laboratory, IRMB, St Eloi University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276690
- Sponsor's protocol ID
- 9190
- Acronym
- HEPCIDANE
- Status last verified
- Nov 2015
- First submitted
- 16 Oct 2014
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28919067Lasocki 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.
PubMed 33588893
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02276690
- Acronym / sponsor ID
- HEPCIDANE / 9190
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- 26 Oct 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dosage of hepcidin | Experimental | Biological: hepcidinIn order to assess iron deficiency, patients randomized in this arm will have dosage of hepcidin by mass spectrometry |
| Usual biomarker dosage | Active comparator | Biological: ferritin and transferrin saturationIn order to assess iron deficiency, patients randomized in this arm will have usual biomarker dosages (ferritin and transferrin saturation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepcidinIn 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 | Biological | Dosage of hepcidin |
| ferritin and transferrin saturationIn 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. | Biological | Usual biomarker dosage |
Primary outcome
Hospital cost
Time frame: from Intensive Care Unit discharge to 90 days after (D90)
7 secondary outcomes
Lenght of hospital stay post-Intensive Care Unit
Time frame: until day 90 after Intensive Care Unit discharge
Haemoglobin levels
Time frame: 15 days post-Intensive Care Unit discharge
Iron deficiency prevalence
Time frame: at Day 15 after Intensive Care Unit discharge
Fatigue
Time frame: 30 days after Intensive Care Unit discharge
Proportion of patient alive
Time frame: at Day 90 after Intensive Care Unit discharge
Proportion of patient at home
Time frame: at Day 90 after Intensive Care Unit discharge
Comparison between mass spectrometry and immuno-detection methods for hepcidin quantification (ancillary study)
Time frame: from inclusion to Day15 after Intensive Care Unit discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 28919067Lasocki 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.
- Derived from this study: PubMed 33588893Lasocki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigismond SL LASOCKI, PU-PH study director
Department of Anesthesiology & Critical Care, Angers University Hospital, France
Sylvain SL LEHMANN, PU-PH study chair
Biochemistry and clinical proteomic laboratory, IRMB, St Eloi University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hepcidin and ferritin and transferrin saturation in people with Anemia and Critical Illness, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital cost (time frame: from Intensive Care Unit discharge to 90 days after (D90)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02276690, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.