Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.

January 19, 2022 updated by: Piotr Czempik, Medical University of Silesia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Katowice, Poland, 40-752
        • Recruiting
        • University Clinical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalised in the intensive care unit diagnosed with sepsis/septic shock

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 19, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCN-2-083/N/O/K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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