Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.

NCT05217836 | Unknown

• 1 other identifier: PCN-2-083/N/O/K
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ferritin; transferrin; transferrin saturation; hepcidin; reticulocyte hemoglobin content; parenteral iron

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Interventions

ferritin; iron; transferrin; transferrin saturation; hemoglobin in reticulocyte; hepcidin DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• active bleeding
• erythrocyte mean corpuscular volume (MCV) above the reference range
• diagnosed thalassemia or suspicion of thalassemia based on Mentzer index \[9\]
• pregnancy

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

University Clinical Center

Katowice, 40-752, Poland

RECRUITING

Related Publications (11)

• 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.

  PMID: 24297872 BACKGROUND

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

  PMID: 18390780 BACKGROUND

• 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. doi: 10.1097/01.CCM.0000104112.34142.79.

  PMID: 14707558 BACKGROUND

• 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.

  PMID: 29050512 BACKGROUND

• 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.

  PMID: 31926739 BACKGROUND

• Meybohm P, Richards T, Isbister J, Hofmann A, Shander A, Goodnough LT, Munoz 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.

  PMID: 27317382 BACKGROUND

• Munoz 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.

  PMID: 27996086 BACKGROUND

• Wish JB. Assessing iron status: beyond serum ferritin and transferrin saturation. Clin J Am Soc Nephrol. 2006 Sep;1 Suppl 1:S4-8. doi: 10.2215/CJN.01490506.

  PMID: 17699374 BACKGROUND

• 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.

  PMID: 27195903 BACKGROUND

• 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.

  PMID: 26903338 BACKGROUND

• Mentzer WC Jr. Differentiation of iron deficiency from thalassaemia trait. Lancet. 1973 Apr 21;1(7808):882. doi: 10.1016/s0140-6736(73)91446-3. No abstract available.

  PMID: 4123424 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Sepsis; Shock, Septic

Interventions

Reticulocyte Count

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Erythrocyte Count; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Piotr F Czempik, MD, PhD

CONTACT

0048327894201; pczempik@sum.edu.pl

Agnieszka Wiórek, MD

CONTACT

0048327894201; agnieszka.wiorek@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (assistant)/lecturer

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 1, 2022
• Study Start: September 24, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)