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

• Conditions: Anemia of Acute Inflammation

• Registration Number: NCT01589874
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2012-03
• Study First Submitted: 2012-03-06
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-30
• Last Update Submitted: 2012-04-30
• Study First Posted: 2012-05-02
• Last Update Posted: 2012-05-02
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Internal Medicine Department - U.O. Medicina Interna 1/A; 🇮🇹 via Francesco Sforza 35, Milan, Italy