Clinical trial NCT05217836: Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Official title: Iron Metabolism Disorders in Patients With Sepsis or Septic Shock. Diagnosis and Monitoring of Treatment Based on Standard and New Laboratory Parameters.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iron-deficiency
Iron Deficiency Anemia
Anemia of Chronic Disease
Sepsis
Septic Shock
Keywords: ferritin
transferrin
transferrin saturation
hepcidin
reticulocyte hemoglobin content
parenteral iron
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalised in the intensive care unit diagnosed with sepsis/septic shock

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* diagnosis of sepsis or septic shock according to the third international definition and appropriate diagnostic criteria

Exclusion Criteria:

* active bleeding
* erythrocyte mean corpuscular volume (MCV) above the reference range
* diagnosed thalassemia or suspicion of thalassemia based on Mentzer index \[9\]
* pregnancy

Primary outcomes:
measure: 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
timeFrame: Through study completion, an average of 1 year
measure: 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
timeFrame: Through study completion, an average of 1 year
measure: 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
timeFrame: Through study completion, an average of 1 year
measure: 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
timeFrame: Through study completion, an average of 1 year
measure: 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
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: University Clinical Center
Study officials:
References:
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citation: Mentzer WC Jr. Differentiation of iron deficiency from thalassaemia trait. Lancet. 1973 Apr 21;1(7808):882. doi: 10.1016/s0140-6736(73)91446-3. No abstract available.