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

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

This study has been completed.

First Received: June 16, 2006 Last Updated: May 5, 2008 History of Changes

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris SFAR (societe française d'anesthesie réanimation) Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00338234

Purpose

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

Condition
Anemia Intensive Care Cardiac Surgery

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients, Role of Hepcidin

Resource links provided by NLM:

MedlinePlus related topics: Anemia Heart Surgery Surgery

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Functional iron deficiency [ Time Frame: during the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

fatigue assessed by the MFI20 score for cardiac surgery patients [ Time Frame: at one day,at seven days and at 28 days ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Blood serum

Enrollment:	153
Study Start Date:	June 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cardiac surgery Successive cardiac surgery patients
Surgical ICU Successive patients admitted to the surgical ICU for more than 7 days, and experiencing anemia

Detailed 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.

Eligibility

Ages Eligible for Study:	20 Years to 88 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

For the surgery :population 20 yers to 88 years old
For the reanimation : population to the 41 years to 85 years old

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338234

Locations

France
APHP, hopital Bichat
Paris, France, 75018

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

SFAR (societe française d'anesthesie réanimation)

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Principal Investigator:	sigismond lasocki, MD	Assistance Publique - Hôpitaux de Paris
Study Chair:	Carole Beaumont, PhD	Institut National de la Santé Et de la Recherche Médicale, France
Study Chair:	Isabelle Boutron, MD	Institut National de la Santé Et de la Recherche Médicale, France

More Information

No publications provided

Responsible Party:	CHU BICHAT-Claude BERNARD ( Sigismond LASOCKI )
Study ID Numbers:	FAIRe
Study First Received:	June 16, 2006
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00338234 History of Changes
Health Authority:	France: Institutional Ethical Committee

Keywords provided by Assistance Publique - Hôpitaux de Paris:

anemia
intensive care
cardiac surgery
iron metabolism
hepcidin

Study placed in the following topic categories:

Hematologic Diseases
Anemia
Iron

Additional relevant MeSH terms:

Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on September 02, 2009