Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients

Anemia Clinical Trial

— FAIRe  

Official title:

Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients, Role of Hepcidin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338234
• Other study ID #: FAIRe
• Status: Completed
• Phase: N/A
• First received: June 16, 2006
• Last updated: May 5, 2008
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: April 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation.

Description:

Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation. The latter is known to interfere with iron metabolism, inducing iron storage instead of using it for hemoglobin synthesis. The discover of a new regulatory hormone of iron metabolism, hepcidin, may help us to better understand the link between inflammation and iron functional deficit. The aim of our study is to observe the variation of usual iron metabolism biological markers and of hepcidin, in order to define the better marker of iron loss in these clinical situations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 88 Years

Eligibility

Inclusion Criteria:

• Anemia (haemoglobin < 10 g/dL)

• Hospitalization in ICU for an expected duration of 7 days or more

• Or, day one post cardiac surgery

Exclusion Criteria:

• Chronic anemia (Hb < 9 g/dL for more than one month before hospitalization)

• Iron metabolism disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Cardiac Surgery
• Intensive Care

Locations

Country	Name	City	State
France	APHP, hopital Bichat	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France, Société Française d'Anesthésie et de Réanimation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional iron deficiency		during the study	No
Secondary	fatigue assessed by the MFI20 score for cardiac surgery patients		at one day,at seven days and at 28 days	No