Status:
COMPLETED
Evaluation of Oxidative Stress Induced by Iron Injection in Healthy Volunteers and Critical Care Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Critical Illness
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the pro-oxidant toxicity of iron injections in critically ill patients and in healthy volunteers. The investigators hypothesize that the inflammatory state of ...
Detailed Description
Anemia is frequent among critically ill patients, with 60% of the patients being anemic at admission and more than 80% at discharge. This anemia is associated with an increased MORBI-mORTALITY. Howeve...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Man or woman hospitalized in critical care unit,
- between 18 and 90 years old
- clinical examination completed
- written consent from the patient or a patient's relative depending on the awareness of the patient
- an iron injection has been prescribed by the responsible physician to the patient
- anemia defined as hemoglobin level ≤11 g/dl
- iron deficiency define by at least one of the following criteria :
- ferritin \< 100 μg/l
- ferritin between 100 and 300 μg/l with transferrin saturation \< 20%,
- soluble transferrin receptor (RsTf) ≥1,4 mg/l,
- ratio RsTf/log(ferritin) ≥0,7,
- blood loss ≥ 1 blood weight.
- EXCLUSION CRITERIA:
- do not subscribe to the french health insurance program
- Pregnancy or nursing
- past medical history of iron overload or disfunction in iron metabolism (= primary or secondary hemochromatosis)
- Recent bacteremia defined as positive in the 48 hours preceding the injection. Having a non positive hemoculture is not an exclusion criteria
- Suspicion of a novel current infection defined by a new fever with temperature over \>38°5 for at least three times during the last 48hours. A persisting fever for more than 48 hours without argument for a new infection is not an exclusion criteria.
- known allergia to the iron- hydroxide complex or one of the excipient
- active chronic alcoholism
- oral iron treatment during the last 24 hours. Usage of antioxidant (vitamin C, vitamin E) within the 24 hours preceding the iron injection.
- person participating to another clinical trial or being in the exclusion phase of a clinical trial
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01443624
Start Date
October 1 2011
End Date
August 1 2013
Last Update
August 14 2013
Active Locations (1)
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1
CHU Bichat-Claude Bernard
Paris, France, 75018