Iron Status Assessment in Geriatric Elderly
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age75+
SponsorCentre Hospitalier Régional d'Orléans
About this trial
In elderly adults, anemia is common and multifactorial. Inflammation, which is frequently observed in hospitalized elderly patients, profoundly alters iron metabolism, making it difficult to accurately assess true iron status.
The objective of this study is to identify a predictive model that can estimate iron deficiency status in the absence of inflammation using transferrin saturation (TSAT) measured during an inflammatory phase. This model could help distinguish true iron deficiency from anemia of inflammation, improve patient management, and reduce decision-making delays.
The study will be conducted in two distinct phases: a pilot phase involving up to 200 patients at a single center in France, followed by a main phase involving 1,523 patients across multiple centers in France. Participants will be adults aged over 75 years who are hospitalized in a geriatric ward and present with an acute inflammatory episode (C-reactive protein \[CRP\] \> 50 mg/L).
In addition to routine analyses performed during hospitalization, supplementary laboratory analyses will be carried out. Following admission in hospital, patients will receive standard medical care. Upon admission or on the following day, patients, their trusted representative, or relatives will be informed about the study. If eligibility criteria are met, the patient will be enrolled.
Research-specific laboratory analyses will be performed on blood samples collected at 4 times:
* the day after admission; * when CRP \< 20 mg/L (pilot phase only); * when CRP \< 10 mg/L; * five days after a CRP \< 10 mg/L. These additional analyses will not require another blood sample, as they will be performed on samples collected as part of routine clinical care. They constitute the main research specific intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 75 years.
Hospitalization with CRP > 50 mg/L at admission.
Non-opposition expressed by patient or legally authorized representative
Disqualifiers
Advanced chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m²) or chronic dialysis.
Severe hepatic impairment (Child-Pugh score B or C).
Severe hematological disorders (active hematologic malignancy or known myelodysplastic syndrome) or known iron metabolism disorders that may bias the study results (e.g., thalassemia, advanced hemochromatosis).
Hemoglobin < 9g/L
Trial population
Eligible patients will be recruited from among elderly adults hospitalized for acute condition associated with a biologically documented inflammatory syndrome and for whom laboratory follow-up can be performed during and after the acute inflammatory episode.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Analysis of biological parameters
Diagnostic testResearch-specific analyses will be performed on the following blood samples: * Day 0 : reticulocyte count, reticulocyte hemoglobin content (Ret-He), percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (TSAT, %), ferritin, soluble transferrin receptor, and hepcidin. * CRP \< 20 mg/L (pilot phase only): reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, TSAT (%), ferritin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), total bilirubin, albumin, and creatine phosphokinase (CPK). * CRP \< 10 mg/L: reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, TSAT (%), ferritin, , AST, ALT, AP, total bilirubin, albumin, and CPK. * 5 days after CRP \< 10 mg/L: same as CRP \< 10 mg/L
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Elderly patients with acute inflammation1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with iron deficiency, defined as transferrin saturation < 20% (pilot phase)
To estimate the proportion of patients with iron deficiency, defined as transferrin saturation (TSAT) \< 20%, in order to validate the prevalence assumption that will be used in the sample size calculation for the development of a predictive model of iron deficiency under non-inflammatory conditions
Time frame
From enrollment to the end of study at 4 weeks maximum2
To develop a predictive model for iron deficiency, defined by TSAT under non-inflammatory conditions (defined as CRP<10 mg/L or <20 mg/L, depending on results of pilot phase), using measurements obtained during acute inflammatory episode (main phase)
Transferrin saturation (TSAT) will be measured at baseline and when CRP \< 10 mg/L (or \< 20 mg/L, depending on results of the pilot phase). Iron deficiency will be defined as a TSAT \< 20%. The predictive performance of the model for estimating TSAT under non-inflammatory conditions and the agreement between predicted and observed TSAT values under non-inflammatory conditions will be assessed.
Time frame
From enrollment to the end of study at 4 weeks maximumSecondary outcomes
1
Proportion of patients with CRP < 20 mg/L and proportion of patients with CRP < 10 mg/L in the study population (pilot phase)
To estimate the proportion of patients with CRP \< 20 mg/L and the proportion of patients with CRP \< 10 mg/L, in order to refine the study population for the development of the predictive model of iron deficiency under non-inflammatory conditions.
Time frame
From enrollment to the end of study at 4 weeks maximum2
Among the clinically relevant variables, and within subgroups of patients with CRP < 20 mg/L and < 10 mg/L (pilot phase), to examine a/the collinearity structure among potential predictors ; b/the distribution of categorical variables
For collinearity: Associations between candidate predictors will first be assessed through bivariate analyses (Spearman's or Pearson's correlation coefficient for two continuous variables, Cramér's V for two categorical variables, and point-biserial correlation for a continuous/binary variable pair), using a predefined alert threshold of \|r\| or V \> 0.7. A variance inflation factor (VIF) will then be calculated for each predictor retained after this initial step; variables with a VIF \> 5 will be excluded. For rare categories: Frequency distributions will be examined for each categorical variable. A category will be considered too rare if it represents less than 5% of the subgroup sample size.
Time frame
From enrollment to the end of study at 4 weeks maximum3
To assess the correlation between transferrin saturation measured during an inflammatory state and transferrin saturation measured under non-inflammatory conditions.
Correlation between transferrin saturation measured during inflammation (baseline sample) and transferrin saturation measured once C-reactive protein (CRP) levels have decreased to \< 10 mg/L.
Time frame
From enrollment to the end of study at 4 weeks maximum4
To develop and validate a predictive model for iron deficiency, defined by ferritin levels under non-inflammatory conditions, with non-inflammation defined as CRP < 10 mg/L (or < 20 mg/L, depending on the results of the pilot phase).
Ferritin will be assessed at baseline and when CRP is \< 10 mg/L (or \< 20 mg/L, depending on the results of the pilot phase). Iron deficiency will be defined by a ferritin level \< 100 µg/L. The predictive performance of the model for estimating ferritin under non-inflammatory conditions and the agreement between predicted and observed ferritin values under non-inflammatory conditions will be assessed.
Time frame
From enrollment to the end of study at 4 weeks maximumSponsors and contacts
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Source ClinicalTrials.gov