Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (iron supplementation) | Patients who have received oral or IV iron as part of routine care for a ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20%. | ||
| Group B (without iron supplementation) | Patients who did not receive iron, despite a ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20%. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Mean increase in hemoglobin | The improvement in anemia, represented by the mean hemoglobin level (g/L) measured at 3 months after hospitalization, between patients who received iron supplementation and those who did not.
| At 3 months (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Correction of anemia : | Proportion of patients having corrected their anemia (hemoglobin level ≥ 13 g/dL in men, ≥ 12 g/dL in women).
| At 3 months (end of study) |
Not provided
Inclusion Criteria :
Exclusion Criteria :
Not provided
Not provided
Not provided
Subjects included in the study will be recruited from patients hospitalised in the various units of the Internal and Polyvalent Medicine Department at Grenoble Alpes University Hospital (Internal Medicine 3eA, Post-Emergency Unit 3eB and Internal Medicine 3eC).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruna DUCOTTERD, Clinical Research Associate | Contact | +33 4 76 76 78 38 | bducotterd@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Alexis BOCQUET, Hospital Doctor | University Hospital, Grenoble Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Grenoble Alpes | La Tronche | 38700 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34693519 | Background | 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. | |
| 36479498 | Background |
| Label | URL |
|---|---|
| " HAS 2011 - Choix des examens du métabolisme du fer en cas de suspicion de carence martiale - texte long ", s. d. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Identify factors associated with anemia correction |
Analysis of demographic (age, gender), clinical (comorbidities) and biological factors
|
| At 3 months (end of study) |
| Adverse events : | Incidence of adverse effects associated with iron supplementation (hypersensitivity, iron overload).
| At 3 months (end of study) |
| 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. |
| 27321965 | Result | 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. |
| 30803900 | Result | 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. |
| 36060352 | Result | 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. |
| 31443557 | Result | 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. |
| 27827838 | Result | 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. |
| KIANI et al., " Main nutritional deficiencies ". | View source |
| " Revue Médicale Suisse 2011 ; 7 : 2018-23 RMS\_idPAS\_D\_ISBN\_pu2011-37s\_sa03\_art03.pdf " | View source |
| " HAS 2011 - Choix des examens du métabolisme du fer en cas de suspicion de carence martiale - texte long " | View source |
| World Health Organization, WHO Guideline on Use of Ferritin Concentrations to Assess Iron Status in Individuals and Populations (Geneva: World Health Organization, 2020) | View source |
| Aurelien Amiot et al., " Practice guidelines for the diagnosis and management of ulcerative colitis " 29 (2022). | View source |
| " KDIGO-2012-Anemia-Guideline-English.pdf ", consulté le 24 novembre 2024 | View source |
| " 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure \| Journal de Cardiologie " | View source |
| "ANSM 1997 - Hémogramme " | View source |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided