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

NCT ID: NCT01589874

Last Updated: 2012-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Anemia of Acute Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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acute ill patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milano Bicocca

OTHER

Sponsor Role collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Principal Investigators

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Giovanna Fabio, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universita' degli Studi di Milano & Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Giovanna Fabio, MD, PhD

Role: STUDY_DIRECTOR

Universita' degli Studi di Milano & Fondazione IRCCS Ca' Granda Osepdale Maggiore Policlinico

Locations

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Internal Medicine Department - U.O. Medicina Interna 1/A

Via Francesco Sforza 35, Milan, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giovanna Fabio, MD, PhD

Role: CONTACT

+390255033563

Maria Carrabba, MD

Role: CONTACT

+390255033353

Facility Contacts

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Giovanna Fabio, MD, PhD

Role: primary

+390255033563

Maria Carrabba, MD

Role: backup

+390255033353

Other Identifiers

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328/2007

Identifier Type: -

Identifier Source: org_study_id

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