Anemia of Inflammation: Investigation on Impaired Iron Regulation in Acutely Ill Patients and Their Clinical Outcome

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01589874

Enrollment

100

Registered

2012-05-02

Start date

2008-01-31

Completion date

2014-12-31

Last updated

2012-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia of Acute Inflammation

Keywords

hepcidin, anemia, acute inflammation, IL-6, cytokines

Brief summary

Anemia of inflammation (AI), a normochromic, normocytic anemia, associated with abnormal iron utilization, erythropoietin hyporesponsiveness, and decreased red blood cells (RBC) survival is a very common problem in hospitalized patients for acute inflammatory diseases and develops within few days from the onset of illness. Deleterious effects of anemia include increased risk of cardiac related morbidity and mortality in critically ill and older patients. Anemia is mediated by hepcidin, the 25-amino acid polypeptide hormone that is central to iron trafficking. Several studies have been performed on pathophysiology of AI in patients affected by chronic diseases but few explore iron metabolism in humans with acute inflammation. The aim is to develop effective new strategies to detect and manage AI in the setting of acutely ill patients, based on the understanding of iron balance underlying this disorder.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

(both): * serum C-reactive protein level \> 3mg/dL * creatinine level \< 2mg/dL (clearance \> 30%)

Exclusion criteria

* any haematological diseases * cancer under chemotherapy * AIDS (or HIV+) * liver cirrhosis * genetic hemochromatosis * immunosuppressive therapy * blood transfusion in the past 30-days

Design outcomes

Primary

Measure	Time frame	Description
impact of acute inflammatory state on hemoglobin levels	6 days - 8 days	Hemoglobin levels, Blood Red Cells markers, C-RP and other routinary inflammatory markers on day 1 and day 6 (or 8), IL-1, IL-4, IL-6, IL-10, alpha-TNF, gamma-IFN, GDF-15, erythropoietin and hepcidin on day 1 and on day 6 (or 8)

Secondary

Measure	Time frame	Description
impact of acute inflammatory cytokines on hepcidin-driven iron balance and monocytes role in anemia of acute inflammation	6 days - 8 days	serum iron levels, ferritin and transferrin saturation, circulating monocytes and their HAMP mRNA.

Countries

Italy

Contacts

Primary ContactGiovanna Fabio, MD, PhD

giovanna.fabio@unimi.it+390255033563

Backup ContactMaria Carrabba, MD

maria.carrabba@gmail.com+390255033353

Outcome results