Anemia of Inflammation: Investigation on Impaired Iron Regulation in Acutely Ill Patients and Their Clinical Outcome
Recruitment status was: Recruiting
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.
Anemia of Acute Inflammation
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Anemia of Inflammation: Investigation on Impaired Iron Regulation in Acutely Ill Patients and Their Clinical Outcome|
- impact of acute inflammatory state on hemoglobin levels [ Time Frame: 6 days - 8 days ] [ Designated as safety issue: Yes ]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)
- impact of acute inflammatory cytokines on hepcidin-driven iron balance and monocytes role in anemia of acute inflammation [ Time Frame: 6 days - 8 days ] [ Designated as safety issue: Yes ]serum iron levels, ferritin and transferrin saturation, circulating monocytes and their HAMP mRNA.
Biospecimen Retention: Samples With DNA
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|acute ill patients|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589874
|Internal Medicine Department - U.O. Medicina Interna 1/A|
|via Francesco Sforza 35, Milan, Italy, 20122|
|Principal Investigator:||Giovanna Fabio, MD, PhD||Universita' degli Studi di Milano & Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico|
|Study Director:||Giovanna Fabio, MD, PhD||Universita' degli Studi di Milano & Fondazione IRCCS Ca' Granda Osepdale Maggiore Policlinico|