Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05217836
• Other study ID #: PCN-2-083/N/O/K
• Status: Recruiting
• Start date: September 24, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Medical University of Silesia
• Contact: Piotr F Czempik, MD, PhD
• Phone: 0048327894201
• Email: pczempik[@]sum.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia of Chronic Disease
• Anemia, Iron-Deficiency
• Chronic Disease
• Iron Deficiency Anemia
• Iron Metabolism Disorders
• Iron-deficiency
• Metabolic Diseases
• Sepsis
• Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
Poland	University Clinical Center	Katowice

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

References & Publications (11)

Buttarello M. Laboratory diagnosis of anemia: are the old and new red cell parameters useful in classification and treatment, how? Int J Lab Hematol. 2016 May;38 Suppl 1:123-32. doi: 10.1111/ijlh.12500. Epub 2016 May 16. Review. — View Citation

Clark SF. Iron deficiency anemia. Nutr Clin Pract. 2008 Apr-May;23(2):128-41. doi: 10.1177/0884533608314536. Review. — View Citation

Corwin HL, Gettinger A, Pearl RG, Fink MP, Levy MM, Abraham E, MacIntyre NR, Shabot MM, Duh MS, Shapiro MJ. The CRIT Study: Anemia and blood transfusion in the critically ill--current clinical practice in the United States. Crit Care Med. 2004 Jan;32(1):39-52. — View Citation

Czempik PF, Wojnarowicz O, Krzych LJ. Let us use physiologic transfusion triggers: Favorable outcome in an 86-year-old Jehovah's witness with a haemoglobin nadir of 44g L(-1). Transfus Apher Sci. 2020 Apr;59(2):102718. doi: 10.1016/j.transci.2020.102718. Epub 2020 Jan 7. — View Citation

Kassebaum NJ, Jasrasaria R, Naghavi M, Wulf SK, Johns N, Lozano R, Regan M, Weatherall D, Chou DP, Eisele TP, Flaxman SR, Pullan RL, Brooker SJ, Murray CJ. A systematic analysis of global anemia burden from 1990 to 2010. Blood. 2014 Jan 30;123(5):615-24. doi: 10.1182/blood-2013-06-508325. Epub 2013 Dec 2. — View Citation

Mentzer WC Jr. Differentiation of iron deficiency from thalassaemia trait. Lancet. 1973 Apr 21;1(7808):882. — View Citation

Meybohm P, Richards T, Isbister J, Hofmann A, Shander A, Goodnough LT, Muñoz M, Gombotz H, Weber CF, Choorapoikayil S, Spahn DR, Zacharowski K. Patient Blood Management Bundles to Facilitate Implementation. Transfus Med Rev. 2017 Jan;31(1):62-71. doi: 10.1016/j.tmrv.2016.05.012. Epub 2016 May 28. Review. — View Citation

Muñoz M, Acheson AG, Auerbach M, Besser M, Habler O, Kehlet H, Liumbruno GM, Lasocki S, Meybohm P, Rao Baikady R, Richards T, Shander A, So-Osman C, Spahn DR, Klein AA. International consensus statement on the peri-operative management of anaemia and iron deficiency. Anaesthesia. 2017 Feb;72(2):233-247. doi: 10.1111/anae.13773. Epub 2016 Dec 20. — View Citation

Musallam KM, Taher AT. Iron deficiency beyond erythropoiesis: should we be concerned? Curr Med Res Opin. 2018 Jan;34(1):81-93. doi: 10.1080/03007995.2017.1394833. Epub 2017 Nov 3. Review. — View Citation

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. — View Citation

Wish JB. Assessing iron status: beyond serum ferritin and transferrin saturation. Clin J Am Soc Nephrol. 2006 Sep;1 Suppl 1:S4-8. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

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