CClinicalTrials.gg
Status unknownNCT04281888Updated Feb 24, 2020

Inflammatory Anemia Associated Parameters in Septic Patients

An observational study in Inflammatory Response, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-24.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 75 Years
Sex
All
01

Study summary

  1. To observe the changes in the inflammatory anemiaassociated parameters of patients with sepsis in the early stage of intensive care unit (ICU) admission.
  2. To evaluate their association with 28-days mortality
  3. To evaluate the effect of blood transfusion on these parameters and the survival of the studied patients
Read the detailed description

Anemia is one of the most common complications in patients with sepsis in the intensive care unit (ICU), as well as sepsis is a major cause of high mortality in ICU. Studies demonstrated that sepsis-related anemia can be caused by fluid loading related hemodilution, iatrogenic blood loss, decreases in iron supply, erythropoietin (EPO) production and erythrocyte lifespan .

However, sepsis related anemia has been demonstrated to be associated mainly with inflammation (i.e., "anemia of inflammation"). Anemia of inflammation is usually a mild to moderately severe anemia (hemoglobin rarely \< 8 g/dL) . It develops in the setting of infection, inflammatory disease or malignancy, together with low serum iron despite adequate systemic iron stores, decreased serum transferrin, normal size of erythrocytes and hemoglobin content or mildly decreased size and hemoglobin content of erythrocytes if the inflammatory disease is longstanding .

Impaired iron homeostasis and the suppressive effects of proinflammatory cytokines on erythropoiesis, together with alterations in the erythrocyte membrane that impair its survival may result, ultimately, in inflammation-associated anemia .

Hepcidin is a key regulator of inflammation-associated anemia. Hepcidin reduces the iron level in plasma through:

  1. direct inhibition of intestinal absorption of iron.
  2. promotion of iron storage in macrophages by down regulating expression of ferroprotein in intestinal mucosae and macrophages.

Increased interleukin-6 (IL-6) in patients with sepsis can induce an abruptly increased synthesis of hepcidin, causing decreased plasma iron. Plasma iron can be depressed by inflammation markedly (more than 50%) and rapidly ( with in 24 hrs). Also, the interaction between inflammation and iron metabolism may interfere with other inflammatory anemia associated parameters and complicate iron metabolism in patients with sepsis.

Typically, plasma ferritin (which stores iron) is reduced in iron deficiency anemia but can increase in the acute phase of sepsis. Anemia usually results in an increased synthesis of EPO in kidneys in minutes to hours, but the response to EPO is blunted in patients with sepsis . The soluble transferrin receptor (sTfR), an early and sensitive biomarker for diagnosing iron deficiency , is particularly useful for identification of concomitant iron deficiency in patients with inflammation. The sTfR is not affected by inflammation, which is a significant advantage over other biomarkers. Plasma sTfR reflects the degree of iron availability for cells, whereas plasma ferritin reflects iron storage. Hence, the ratio of sTfR to log ferritin (hereafter termed "sTfR/log ferritin") provides the efficacy of sTfR alone or ferritin alone in the diagnosis of iron deficiency. These cytokines have the propensity to promote iron restricted erythropoiesis, characterized by functional rather than absolute iron deficiency, occurring secondary to dysregulation of iron metabolism.

Associations among inflammatory cytokines, EPO, and anemia in critically ill septic patients remain unclear.

The inflammatory anemia-associated parameters mentioned above may change with the severity of inflammation in patients with sepsis. The sensitivity and specificity of these parameters can be modified if inflammation and iron deficiency are present concomitantly. This may complicate the diagnosis, evaluation, and treatment of inflammatory anemia.

Hence, a better understanding of changes in the inflammatory anemia and associated parameters in patients with sepsis at the early stage of ICU admission is needed urgently. In addition, although severe anemia is associated with adverse outcomes in critical illness, a lowered plasma iron is part of the natural defense against pathogens.

EPO has also been demonstrated to exert protective effects in the kidneys and lungs of mice with sepsis, but EPO deficiency contributes to anemia development in patients with sepsis. As a result of these effects, inflammatory anemia-associated parameters have been speculated to be associated with the prognosis of patients with sepsis , but relevant studies are lacking

02

Conditions studied

  • Inflammatory Response

Browse trials for

03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 326 observational studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients in ICU with sepsis

Eligibility criteria

Inclusion Criteria:

1-patients meeting diagnostic criteria of sepsis and hemoglobin level less than 10 g/dl 2-patients admitted to the intensive care unit Exclusion Criteria

  1. patients less than18 years of age.
  2. patients have chronic liver dysfunctions or chronic kidney disease resulting from different causes.
  3. patients with known iron related diseases (e.g., hemochromatosis), immunologic diseases or malignancies upon hospital admission; all types of anemia (aplastic, iron deficiency, hemolytic, megaloblastic).
  4. patients with overt blood loss (e.g., gastrointestinal bleeding) upon admission and during the ICU stay.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. The relation between level of hepcidin, interleukin-6 and hemoglobin with 28-days mortality in 100 ICU septic patients

    Hepicidin level will be measured in day 1,3 and 7 of ICU admission as well as interleukin-6 and hemoglobin and the relation between their level and survival of the studied patients will be evaluated

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Ganz T, Nemeth E. Iron homeostasis in host defence and inflammation. Nat Rev Immunol. 2015 Aug;15(8):500-10. doi: 10.1038/nri3863. Epub 2015 Jul 10. PubMed 26160612 ↗
  • Hegde A. Approach to an Anemic Critically Ill Patient. Indian J Crit Care Med. 2019 Sep;23(Suppl 3):S178-S180. doi: 10.5005/jp-journals-10071-23247. PubMed 31656373 ↗
  • Weiss G, Ganz T, Goodnough LT. Anemia of inflammation. Blood. 2019 Jan 3;133(1):40-50. doi: 10.1182/blood-2018-06-856500. Epub 2018 Nov 6. PubMed 30401705 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04281888
Lead sponsor
Assiut University
Responsible party
Heba Mohamed Ahmed (Hematologist, Assiut University) — Principal investigator
First posted
Feb 24, 2020
Start date
Mar 20, 2020 (estimated)
Primary completion
Mar 20, 2021 (estimated)
Completion
May 20, 2021 (estimated)
Last update
Feb 24, 2020

Study contacts

Heba M Ahmed, Hematologist
Contact
nfertiti.9981@yahoo.com
00201061343995
Yousreiya A Ahmad, Professor
study director · Assuit University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion