Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.

• Conditions: Anemia of Chronic Disease; Iron Deficiency Anemia; Sepsis; Septic Shock; Iron-deficiency

• Registration Number: NCT05217836
• Lead Sponsor: Medical University of Silesia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-24
• Status Verified: 2022-01
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-19
• Last Update Submitted: 2022-01-19
• Study First Posted: 2022-02-01
• Last Update Posted: 2022-02-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Through study completion, an average of 1 year	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)
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	Through study completion, an average of 1 year	Changes in hemoglobin concentration with consideration of iatrogenic blood loss (blood withdrew for laboratory tests)
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	Through study completion, an average of 1 year	Changes in hemoglobin concentration with consideration of iatrogenic blood loss (blood withdrew for laboratory tests)
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	Through study completion, an average of 1 year	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
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	Through study completion, an average of 1 year	Presence or lack of correlation between the abovementioned laboratory tests

Trial Locations

Locations (1)

University Clinical Center; 🇵🇱 Katowice, Poland