Hepcidine and Iron Deficiency in Critically Ill Patients (HEPCIDANE)
|ClinicalTrials.gov Identifier: NCT02276690|
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : October 6, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||408 participants|
|Intervention Model:||Parallel Assignment|
|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|
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)
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.
- Hospital cost [ Time Frame: from Intensive Care Unit discharge to 90 days after (D90) ]
- 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 ]Fatigue will be assessed by the MFI-20 questionnaire
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276690
|Department of Anesthesiology & Critical Care, Angers University Hospital, 4 rue larrey|
|Angers, France, 49000|
|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|