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

This study is currently recruiting participants.
Verified April 2012 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor:
Collaborator:
Italy: Universita' degli Studi di Milano
Information provided by:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT01589874
First received: March 6, 2012
Last updated: April 30, 2012
Last verified: April 2012
History of Changes
  Purpose

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
Anemia of Acute Inflammation

Study Type: Observational
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

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Further study details as provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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

serum, buffy coat


Estimated Enrollment: 100
Study Start Date: January 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
acute ill patients

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

all consecutive patients admitted to Internal Medicine ward because of acute inflammatory illness

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589874

Contacts
Contact: Giovanna Fabio, MD, PhD +390255033563 giovanna.fabio@unimi.it
Contact: Maria Carrabba, MD +390255033353 maria.carrabba@gmail.com

Locations
Italy
Internal Medicine Department - U.O. Medicina Interna 1/A Recruiting
via Francesco Sforza 35, Milan, Italy, 20122
Contact: Giovanna Fabio, MD, PhD     +390255033563     giovanna.fabio@unimi.it    
Contact: Maria Carrabba, MD     +390255033353     maria.carrabba@gmail.com    
Principal Investigator: Giovanna Fabio, MD, PhD            
Sub-Investigator: Maria Carrabba, MD            
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Italy: Universita' degli Studi di Milano
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01589874     History of Changes
Other Study ID Numbers: 328/2007
Study First Received: March 6, 2012
Last Updated: April 30, 2012
Health Authority: Italy: Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
hepcidin
anemia
acute inflammation
IL-6
cytokines

Additional relevant MeSH terms:
Anemia
Inflammation
Hematologic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013