Sigismond Lasocki1, Hervé Puy2, Grégoire Mercier3, Sylvain Lehmann4. 1. Département anesthésie réanimation, Institut MITOVASC, CNRS UMR 6214, Inserm U1083, Université d'Angers, CHU d'Angers, 4, rue Larrey, 49933 Angers cedex 9, France. Electronic address: sigismond@lasocki.com. 2. Université Paris-Diderot, Sorbonne-Paris-Cité, Paris, France; Inserm U1149, centre de recherche sur l'inflammation, France; Laboratory of excellence, GR-Ex, Paris, France; Hôpital Louis-Mourier, centre français des porphyries, AP-HP, Colombes, France. 3. Département d'informatique médicale, CHU de Montpellier, France. 4. Laboratoire de biochimie - protéomique clinique, CRB de Montpellier, CHU de Montpellier, Montpellier, France.
Abstract
BACKGROUND: Iron deficiency (ID) is frequent but difficult to diagnose in critically ill patients. ID may be responsible for prolonged post-ICU hospital stays, since it results in fatigue, muscle weakness and anaemia. Hepcidin, the key iron metabolism hormone, may be a good marker of ID in these patients. The aim of this study is to determine whether using mass spectrometry hepcidin determination to diagnose (and treat) ID after prolonged ICU stays may reduce patients' subsequent hospital stays and costs in comparison with conventional (ferritin) methods. METHODS: This is a randomised, controlled, single-blinded, multicentre medico-economic study. Hepcidin quantification will be performed in anaemic (WHO criteria) critically ill adults about to be discharged, after a stay ≥5days. In the intervention arm (hepcidin) results will be given to the ICU-physicians, and not in the control arm. ID Treatment will be recommended in intervention arm: IV iron when hepcidin is <20μg/L; IV iron+erythropoietin when hepcidin is between 20-41μg/L; in the control arm: IV iron when ferritin <300μg/L and Transferrin saturation <20%. The primary endpoint will be the number of days spent in hospital 90 days after ICU discharge and the direct hospital costs. Secondary endpoints will be anaemia and iron deficiency on D15, fatigue and the proportion of patients alive and at home on D30 and D90. DISCUSSION: The results of this study will show whether diagnosing iron deficiency using MS hepcidin determination methods is liable to reduce patients' post-ICU hospital stay and costs, as well as their anaemia and fatigue.
RCT Entities:
BACKGROUND:Iron deficiency (ID) is frequent but difficult to diagnose in critically illpatients. ID may be responsible for prolonged post-ICU hospital stays, since it results in fatigue, muscle weakness and anaemia. Hepcidin, the key iron metabolism hormone, may be a good marker of ID in these patients. The aim of this study is to determine whether using mass spectrometry hepcidin determination to diagnose (and treat) ID after prolonged ICU stays may reduce patients' subsequent hospital stays and costs in comparison with conventional (ferritin) methods. METHODS: This is a randomised, controlled, single-blinded, multicentre medico-economic study. Hepcidin quantification will be performed in anaemic (WHO criteria) critically ill adults about to be discharged, after a stay ≥5days. In the intervention arm (hepcidin) results will be given to the ICU-physicians, and not in the control arm. ID Treatment will be recommended in intervention arm: IV iron when hepcidin is <20μg/L; IV iron+erythropoietin when hepcidin is between 20-41μg/L; in the control arm: IV iron when ferritin <300μg/L and Transferrin saturation <20%. The primary endpoint will be the number of days spent in hospital 90 days after ICU discharge and the direct hospital costs. Secondary endpoints will be anaemia and iron deficiency on D15, fatigue and the proportion of patients alive and at home on D30 and D90. DISCUSSION: The results of this study will show whether diagnosing iron deficiency using MS hepcidin determination methods is liable to reduce patients' post-ICU hospital stay and costs, as well as their anaemia and fatigue.
Authors: Robert Szabo; Cristina Petrisor; Constantin Bodolea; Robert Simon; Ioana Maries; Sebastian Tranca; Teodora Mocan Journal: Antioxidants (Basel) Date: 2022-07-14