Anemia of Acute Inflammation Clinical Trial
Official title:
Anemia of Inflammation: Investigation on Impaired Iron Regulation in Acutely Ill Patients and Their Clinical Outcome
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 2014 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Internal Medicine Department - U.O. Medicina Interna 1/A | via Francesco Sforza 35 | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | University of Milano Bicocca |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | impact of acute inflammatory state on hemoglobin levels | 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) | 6 days - 8 days | Yes |
| Secondary | impact of acute inflammatory cytokines on hepcidin-driven iron balance and monocytes role in anemia of acute inflammation | serum iron levels, ferritin and transferrin saturation, circulating monocytes and their HAMP mRNA. | 6 days - 8 days | Yes |