Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.

Last updated: January 19, 2022
Sponsor: Medical University of Silesia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sepsis And Septicemia

Soft Tissue Infections

Metabolic Disorders

Treatment

N/A

Clinical Study ID

NCT05217836
PCN-2-083/N/O/K
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • diagnosis of sepsis or septic shock according to the third international definitionand appropriate diagnostic criteria

Exclusion

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

Total Participants: 90
Study Start date:
September 24, 2021
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • University Clinical Center

    Katowice, 40-752
    Poland

    Active - Recruiting

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