AnemiaFAIReNCT00338234
Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients
An observational study of Anemia and Intensive Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation. Read more about this study
- Who is it for?
- Ages 20 to 88 years
- Conditions the study is for
- Anemia, Intensive Care, Cardiac Surgery
- How many people
- 153 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2006to Dec 2007
- 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 20 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * For the surgery :population 20 yers to 88 years old * For the reanimation : population to the 41 years to 85 years old
Who may be able to join
- Anemia (haemoglobin < 10 g/dL)
- Hospitalization in ICU for an expected duration of 7 days or more
- Or, day one post cardiac surgery
Who cannot join
- Chronic anemia (Hb < 9 g/dL for more than one month before hospitalization)
- Iron metabolism disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia, Intensive Care, Cardiac Surgery
- Keywords
- anemia, intensive care, cardiac surgery, iron metabolism, hepcidin
- 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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Functional iron deficiency
Measured: during the study
Secondary outcomes (1)
fatigue assessed by the MFI20 score for cardiac surgery patients
Measured: at one day,at seven days and at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française d'Anesthésie et de Réanimation, Institut National de la Santé Et de la Recherche Médicale, France
- Investigators
- sigismond lasocki, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisCarole Beaumont, PhD, Study chair, Institut National de la Santé Et de la Recherche Médicale, FranceIsabelle Boutron, MD, Study chair, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338234
- Sponsor's protocol ID
- FAIRe
- Acronym
- FAIRe
- Status last verified
- Apr 2007
- First submitted
- 16 Jun 2006
- Last updated
- 6 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients, Role of Hepcidin
- ClinicalTrials.gov ID
- NCT00338234
- Acronym / sponsor ID
- FAIRe / FAIRe
- Conditions
- Anemia, Intensive Care, Cardiac Surgery
- Keywords
- anemia, intensive care, cardiac surgery, iron metabolism, hepcidin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Société Française d'Anesthésie et de Réanimation, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jun 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Jun 2006 (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 in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery | – | –Successive cardiac surgery patients |
| Surgical ICU | – | –Successive patients admitted to the surgical ICU for more than 7 days, and experiencing anemia |
Who may qualify
- Ages
- 20 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * For the surgery :population 20 yers to 88 years old * For the reanimation : population to the 41 years to 85 years old
Key inclusion criteria (3 listed)
- Anemia (haemoglobin < 10 g/dL)
- Hospitalization in ICU for an expected duration of 7 days or more
- Or, day one post cardiac surgery
Key exclusion criteria (2 listed)
- Chronic anemia (Hb < 9 g/dL for more than one month before hospitalization)
- Iron metabolism disease
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
Functional iron deficiency
Time frame: during the study
1 secondary outcome
fatigue assessed by the MFI20 score for cardiac surgery patients
Time frame: at one day,at seven days and at 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2008.
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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.
sigismond lasocki, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Carole Beaumont, PhD study chair
Institut National de la Santé Et de la Recherche Médicale, France
Isabelle Boutron, MD study chair
Institut National de la Santé Et de la Recherche Médicale, France
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 and Intensive Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 6 May 2008. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional iron deficiency (time frame: during the study). 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 6 May 2008.