An observational study in Iron-deficiency, Iron Deficiency Anemia and Anemia of Chronic Disease, sponsored by Medical University of Silesia. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-01.
Sponsored by Medical University of Silesia · Observational
Anemia is a common health problem. Depending on a geographical region, anemia affects even 50% of population. Among patients admitted to the intensive care unit (ICU) anemia may affect as much as 66% of patients. Moreover, many patients develop anemia during the ICU stay. In general population the most common cause of anemia is iron deficiency (ID). The investigators lack information on the incidence of ID and anemia of inflammation (AI) with absolute ID (mixed type of anemia: AI + IDA) or functional ID (AI) in patients with sepsis or septic shock hospitalised in the ICU. Therefore, the aim of the study is to improve diagnosis of iron deficiency (ID) and anemia of inflammation (AI) with absolute ID (AI + IDA) or functional ID (AI) in patients with sepsis or septic shock.
ID have negative effects on the body and is associated with impaired production of proteins responsible for transport of oxygen in the blood (hemoglobin) and oxygen storage (myoglobin), and impaired immune function. Development of anemia is associated with well documented complications: organ hypoxia, myocardial infarction, stroke, infection. Replenishment of iron at this early stage may potentially prevent IDA. It is advantageous to replenish iron stores in order to avoid these complications, especially in patients with sepsis or septic shock. In IDA red blood cell transfusion is not recommended as it leads to other numerous complications. Therefore the patients presenting with laboratory results suggesting ID will receive divided doses od parenteral iron. Monitoring of iron replenishment will be based on a new laboratory parameter- reticulocyte hemoglobin equivalent.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 90 is below the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Medical University of Silesia is the lead sponsor of 111 studies on the registry; 24 are open to participants now.
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Patients hospitalised in the intensive care unit diagnosed with sepsis/septic shock
Exclusion Criteria:
All patients will have the following laboratory parameters determined: ferritin, iron, transferrin, transferrin saturation, hemoglobin in reticulocyte, hepcidin. Patients with hemoglobin in reticulocyte below reference range will receive parenteral iron.
To assess in patients with sepsis or septic shock the incidence of: iron deficiency, anemia of inflammation with absolute iron deficiency, anemia of inflammation with functional iron deficiency
Incidence of the abovementioned conditions in numbers (%) in patients with sepsis or septic shock based on the results of hemoglobin, hepcidin, reticulocyte hemoglobin equivalent (RET-He)
Time frame: Through study completion, an average of 1 year
To analyze associations between standard (ferritin; transferrin saturation) and new (hepcidin; reticulocyte hemoglobin equivalent) laboratory tests used in diagnosis of anemia in patients with sepsis or septic shock
Presence or lack of correlation between the abovementioned laboratory tests
Time frame: Through study completion, an average of 1 year
To assess the utility of a new diagnostic parameter of iron deficiency (reticulocyte hemoglobin equivalent) in monitoring treatment of iron deficiency in patients with sepsis or septic shock
Assessment of the effect of divided doses of parenteral iron on concentration of reticulocyte hemoglobin equivalent (determinations performed in time intervals of 3-5 days) in patients with sepsis or septic shock
Time frame: Through study completion, an average of 1 year
To assess the effect of divided doses of parenteral iron on anemia in patients with sepsis or septic shock without chronic kidney disease or acute kidney injury requiring renal replacement therapy
Changes in hemoglobin concentration with consideration of iatrogenic blood loss (blood withdrew for laboratory tests)
Time frame: Through study completion, an average of 1 year
To assess the effect of divided doses of parenteral iron and erythropoiesis- stimulating agent (epoetin alpha) on anemia in patients with sepsis or septic shock with chronic kidney disease or acute kidney injury requiring renal replacement therapy
Changes in hemoglobin concentration with consideration of iatrogenic blood loss (blood withdrew for laboratory tests)
Time frame: Through study completion, an average of 1 year
Plan to share: No
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Medical University of Silesia