Iron-deficiencyNCT05217836
Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
An observational study of Iron-deficiency and Iron Deficiency Anemia, run by Medical University of Silesia at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia, Anemia of Chronic Disease
- What is being tested?
- ferritin; iron; transferrin; transferrin saturation; hemoglobin in reticulocyte; hepcidin
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 24 Sep 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalised in the intensive care unit diagnosed with sepsis/septic shock
Who may be able to join
- diagnosis of sepsis or septic shock according to the third international definition and appropriate diagnostic criteria
Who cannot join
- active bleeding
- erythrocyte mean corpuscular volume (MCV) above the reference range
- diagnosed thalassemia or suspicion of thalassemia based on Mentzer index [9]
- pregnancy
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University Clinical Center
Katowice, 40-752
Piotr F Czempik, MD, PhD, 0048327894201, pczempik@sum.edu.pl
About this study
Official title: 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.
- Being tested
- ferritin; iron; transferrin; transferrin saturation; hemoglobin in reticulocyte; hepcidin
- Keywords
- ferritin, transferrin, transferrin saturation, hepcidin, reticulocyte hemoglobin content, parenteral iron
- Medical subject headings
- Anemia, Iron-Deficiency, Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferritin; iron; transferrin; transferrin saturation; hemoglobin in reticulocyte; hepcidinDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start24 Sep 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Czempik, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217836
- Sponsor's protocol ID
- PCN-2-083/N/O/K
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24297872Clark SF. Iron deficiency anemia. Nutr Clin Pract. 2008 Apr-May;23(2):128-41. doi: 10.1177/0884533608314536.
PubMed 18390780Corwin 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.
PubMed 14707558Musallam 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.
PubMed 29050512Czempik 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.
PubMed 31926739Meybohm 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.
PubMed 27317382Munoz 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.
PubMed 27996086Wish 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.
PubMed 17699374Buttarello 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.
PubMed 27195903Singer 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.
PubMed 26903338Mentzer 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.
PubMed 4123424
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Metabolism Disorders in Patients With Sepsis or Septic Shock. Diagnosis and Monitoring of Treatment Based on Standard and New Laboratory Parameters.
- ClinicalTrials.gov ID
- NCT05217836
- Acronym / sponsor ID
- PCN-2-083/N/O/K
- Keywords
- ferritin, transferrin, transferrin saturation, hepcidin, reticulocyte hemoglobin content, parenteral iron
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalised in the intensive care unit diagnosed with sepsis/septic shock
Key inclusion criteria (1 listed)
- diagnosis of sepsis or septic shock according to the third international definition and appropriate diagnostic criteria
Key exclusion criteria (4 listed)
- active bleeding
- erythrocyte mean corpuscular volume (MCV) above the reference range
- diagnosed thalassemia or suspicion of thalassemia based on Mentzer index [9]
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ferritin; iron; transferrin; transferrin saturation; hemoglobin in reticulocyte; hepcidinAll 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. | Diagnostic test | – |
Primary outcome
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)
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
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
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Background: PubMed 24297872Kassebaum 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.
- Background: PubMed 18390780Clark SF. Iron deficiency anemia. Nutr Clin Pract. 2008 Apr-May;23(2):128-41. doi: 10.1177/0884533608314536.
- Background: PubMed 14707558Corwin 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.
- Background: PubMed 29050512Musallam 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.
- Background: PubMed 31926739Czempik 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.
- Background: PubMed 27317382Meybohm 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.
- Background: PubMed 27996086Munoz 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.
- Background: PubMed 17699374Wish 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.
- Background: PubMed 27195903Buttarello 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.
- Background: PubMed 26903338Singer 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.
- Background: PubMed 4123424Mentzer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron-deficiency and Iron Deficiency Anemia, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr F Czempik, MD, PhD (0048327894201, pczempik@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217836, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.