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

May 5, 2008 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • APHP, hopital Bichat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional iron deficiency
Time Frame: during the study
during the study

Secondary Outcome Measures

Outcome Measure
Time Frame
fatigue assessed by the MFI20 score for cardiac surgery patients
Time Frame: at one day,at seven days and at 28 days
at one day,at seven days and at 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Société Française d'Anesthésie et de Réanimation

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 16, 2006

First Submitted That Met QC Criteria

June 16, 2006

First Posted (Estimate)

June 20, 2006

Study Record Updates

Last Update Posted (Estimate)

May 6, 2008

Last Update Submitted That Met QC Criteria

May 5, 2008

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAIRe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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