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

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)

Overall Status

Unknown status

CT.gov ID

NCT01589874

Collaborator

University of Milano Bicocca (Other)

100

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia of Acute Inflammation

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Mar 1, 2012

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
acute ill patients

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Internal Medicine Department - U.O. Medicina Interna 1/A	via Francesco Sforza 35	Milan	Italy	20122

Sponsors and Collaborators

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
University of Milano Bicocca

Investigators

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