Prospective Cohort Study Evaluating Iron Supplementation in Patients With Altered Iron Status in the Context of Acute Inflammation (CARMI (CARence Martiale & Inflammation))

Overview

This study is a prospective, single center, open label cohort study evaluating iron supplementation in patients with impaired martial status in the acute inflammatory setting. The main objective of this study is to evaluate the effectiveness of iron supplementation in anemic patients with inflammation and an altered iron status in the 'grey zone,' defined by a ferritin level between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) of less than 20%, in the patient internal medicine/general medicine unit of the Grenoble Alpes University Hospital. The primary endpoint is the difference in hemoglobin levels at 3 months after hospital discharge between patients treated with or without martial supplementation. We hypothesize that iron supplementation more effectively improves hemoglobin levels at three months compared to no supplementation in patients with anemia and altered iron status (ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) \< 20%) in the context of acute inflammation.

Detailed description

The main objective of this study is to evaluate the effectiveness of iron supplementation in anaemic patients with inflammation and an altered iron status.

The primary endpoint is the difference in hemoglobin levels at 3 months after hospital discharge between patients treated with or without martial supplementation, and our hypothesis is that iron supplementation improves hemoglobin levels at three months compared to no supplementation in patients with anaemia and altered iron status (ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) \< 20%) in the context of acute inflammation.

The secondary objectives are to evaluate the effectiveness of iron supplementation in anaemic and inflammatory patients with iron status in the "grey zone" (ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) \< 20%), to identify demographic, clinical, and biological factors associated with the correction of anaemia in the iron-treated group, to identify demographic, clinical, and biological factors associated with the correction of anaemia in the non-iron-treated group and to assess the safety of iron supplementation.

Anemic patients (hemoglobin \< 13 g/dL in men and \< 12 g/dL in women), with inflammation (CRP \> 30 mg/L), and iron status in the "grey zone" (ferritin between 30 and 300 µg/L and transferrin saturation \< 20%) within the first three days of hospitalization are observed according to the iron supplementation strategy chosen as part of their routine care, allowing for a retrospective classification into two groups:

* Group A: patients who received iron supplementation despite having ferritin between 30 and 300 µg/L and transferrin saturation coefficient (TSC) \< 20%. * Group B: patients who did not receive iron supplementation despite ferritin between 30 and 300 µg/L and transferrin saturation coefficient (TSC) \< 20%.

Sociodemographic and clinical data of the patients in each group will be collected to control for potential confounding factors in the statistical analysis.

Patients are included the day before or at the end of their hospital stay, once all medical decisions-including whether or not to administer iron-have been made independently of the study. No influence is exerted on therapeutic choices, which are based solely on the routine practices of hospital physicians.

Primary outcome measures

• Mean increase in hemoglobin [Time frame: At 3 months (end of study)]

Secondary outcome measures (3)

• Correction of anemia : [Time frame: At 3 months (end of study)]
• Identify factors associated with anemia correction [Time frame: At 3 months (end of study)]
• Adverse events : [Time frame: At 3 months (end of study)]

Eligibility criteria

Inclusion criteria

• Anemia (Hb < 130 g/L in men and < 120 g/L in women) within the first 3 days of hospitalization in the department
• Biological signs of inflammation (CRP ≥ 30 mg/L) within the first 3 days of hospitalization in the department
• Ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20% within the first 3 days of hospitalization in the department

Exclusion criteria

• Patients who object to the use of their data for research purposes
• Patients unable to provide informed consent to participate in the research
• Patients who received a red blood cell transfusion during hospitalization or in the month prior
• Patients receiving erythropoietin (EPO) treatment
• Patients treated with iron supplementation within one month prior to hospitalization
• Congenital hemoglobinopathy (e.g., thalassemia, sickle cell disease)
• Chemotherapy within the past 3 months or planned chemotherapy within the next 3 month

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• University Hospital, Grenoble Alpes — La Tronche

Publications

• Fletcher A, Forbes A, Svenson N, Wayne Thomas D; A British Society for Haematology Good Practice Paper. Guideline for the laboratory diagnosis of iron deficiency in adults (excluding pregnancy) and children. Br J Haematol. 2022 Feb;196(3):523-529. doi: 10.1111/bjh.17900. Epub 2021 Oct 24. No abstract available. PMID 34693519
• Kiani AK, Dhuli K, Donato K, Aquilanti B, Velluti V, Matera G, Iaconelli A, Connelly ST, Bellinato F, Gisondi P, Bertelli M. Main nutritional deficiencies. J Prev Med Hyg. 2022 Oct 17;63(2 Suppl 3):E93-E101. doi: 10.15167/2421-4248/jpmh2022.63.2S3.2752. eCollection 2022 Jun. PMID 36479498
• Shepshelovich D, Rozen-Zvi B, Avni T, Gafter U, Gafter-Gvili A. Intravenous Versus Oral Iron Supplementation for the Treatment of Anemia in CKD: An Updated Systematic Review and Meta-analysis. Am J Kidney Dis. 2016 Nov;68(5):677-690. doi: 10.1053/j.ajkd.2016.04.018. Epub 2016 Jun 16. PMID 27321965
• Romanet T, Bedouch P, Zaoui P. [Assessment of iron deficiency anemia management in the general hospital of Grenoble: A 12-month follow-up of an intravenous ferric carboxymaltose treatment program in a cohort of patients with non-dialysis-dependent chronic kidney disease]. Nephrol Ther. 2019 Apr;15(2):104-109. doi: 10.1016/j.nephro.2018.10.006. Epub 2019 Feb 23. French. PMID 30803900
• Agrawal S, Sonawane S, Kumar S, Acharya S, Gaidhane SA, Wanjari A, Kabra R, Phate N, Ahuja A. Efficacy of Oral Versus Injectable Iron in Patients With Chronic Kidney Disease: A Two-Year Cross-Sectional Study Conducted at a Rural Teaching Hospital. Cureus. 2022 Jul 31;14(7):e27529. doi: 10.7759/cureus.27529. eCollection 2022 Jul. PMID 36060352
• Sieske L, Janssen G, Babel N, Westhoff TH, Wirth R, Pourhassan M. Inflammation, Appetite and Food Intake in Older Hospitalized Patients. Nutrients. 2019 Aug 22;11(9):1986. doi: 10.3390/nu11091986. PMID 31443557
• Petry N, Olofin I, Hurrell RF, Boy E, Wirth JP, Moursi M, Donahue Angel M, Rohner F. The Proportion of Anemia Associated with Iron Deficiency in Low, Medium, and High Human Development Index Countries: A Systematic Analysis of National Surveys. Nutrients. 2016 Nov 2;8(11):693. doi: 10.3390/nu8110693. PMID 27827838

Identifiers

NCT: NCT07014436 · 38RC25.0094

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗