Prospective Cohort Study Evaluating Iron Supplementation in Patients With Altered Iron Status in the Context of Acute Inflammation (CARMI (CARence Martiale & Inflammation))
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean increase in hemoglobin
研究概览
简要总结
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.
详细描述
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%.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean increase in hemoglobin
时间窗: At 3 months (end of study)
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. * Analysis population : All included patients * Statistical tests: * Student's t-test if the data are normally distributed with homogeneity of variances, particularly for hemoglobin. * Wilcoxon non-parametric test if normality assumptions are not met. * Multivariate analysis (ANCOVA) adjusted for potential confounding factors (age, sex, comorbidities, baseline CRP, baseline ferritin, baseline transferrin saturation coefficient (TSC)).
次要结局
- Correction of anemia :(At 3 months (end of study))
- Identify factors associated with anemia correction(At 3 months (end of study))
- Adverse events :(At 3 months (end of study))