NCT05217836

Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.

Iron Metabolism Disorders in Patients With Sepsis or Septic Shock. Diagnosis and Monitoring of Treatment Based on Standard and New Laboratory Parameters.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Medical University of Silesia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ferritin; iron; transferrin; transferrin saturation; hemoglobin in reticulocyte; hepcidin	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.

Timeline

• Start date: 2021-09-24
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-02-01
• Last updated: 2022-02-01

Locations

1 site across 1 country: Poland