Anemia of Acute InflammationNCT01589874
Anemia of Inflammation: Investigation on Impaired Iron Regulation in Acutely Ill Patients and Their Clinical Outcome
An observational study of Anemia of Acute Inflammation, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anemia of Acute Inflammation
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all consecutive patients admitted to Internal Medicine ward because of acute inflammatory illness
Who may be able to join
- serum C-reactive protein level > 3mg/dL
- creatinine level < 2mg/dL (clearance > 30%)
Who cannot join
- any haematological diseases
- cancer under chemotherapy
- AIDS (or HIV+)
- liver cirrhosis
- genetic hemochromatosis
- immunosuppressive therapy
- blood transfusion in the past 30-days
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Internal Medicine Department - U.O. Medicina Interna 1/A
Via Francesco Sforza 35, Milan, 20122
Giovanna Fabio, MD, PhD, +390255033563, giovanna.fabio@unimi.it
Maria Carrabba, MD, +390255033353, maria.carrabba@gmail.com
About this study
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.
Read more
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.
- Conditions
- Anemia of Acute Inflammation
- Keywords
- hepcidin, anemia, acute inflammation, IL-6, cytokines
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute ill patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 days - 8 days
Secondary outcomes (1)
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.
Measured: 6 days - 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startJan 2008
- Primary completionMar 2012
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Acute InflammationStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca
- Investigators
- Giovanna Fabio, MD, PhD, Principal investigator, Universita' degli Studi di Milano & Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoGiovanna Fabio, MD, PhD, Study director, Universita' degli Studi di Milano & Fondazione IRCCS Ca' Granda Osepdale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589874
- Sponsor's protocol ID
- 328/2007
- Status last verified
- Apr 2012
- First submitted
- 6 Mar 2012
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anemia of Inflammation: Investigation on Impaired Iron Regulation in Acutely Ill Patients and Their Clinical Outcome
- ClinicalTrials.gov ID
- NCT01589874
- Acronym / sponsor ID
- 328/2007
- Conditions
- Anemia of Acute Inflammation
- Keywords
- hepcidin, anemia, acute inflammation, IL-6, cytokines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- University of Milano Bicocca
- Study start
- Jan 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 2 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute ill patients | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive patients admitted to Internal Medicine ward because of acute inflammatory illness
Key inclusion criteria (2 listed)
- serum C-reactive protein level > 3mg/dL
- creatinine level < 2mg/dL (clearance > 30%)
Key exclusion criteria (7 listed)
- any haematological diseases
- cancer under chemotherapy
- AIDS (or HIV+)
- liver cirrhosis
- genetic hemochromatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
impact of acute inflammatory state on hemoglobin levels
Time frame: 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)
1 secondary outcome
impact of acute inflammatory cytokines on hepcidin-driven iron balance and monocytes role in anemia of acute inflammation
Time frame: 6 days - 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanna Fabio, MD, PhD principal investigator
Universita' degli Studi di Milano & Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Giovanna Fabio, MD, PhD study director
Universita' degli Studi di Milano & Fondazione IRCCS Ca' Granda Osepdale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia of Acute Inflammation, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanna Fabio, MD, PhD (+390255033563, giovanna.fabio@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of acute inflammatory state on hemoglobin levels (time frame: 6 days - 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2012.