Evaluation of Oxidative Stress Induced by Iron Injection in Healthy Volunteers and Critical Care Patients

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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 critically ill patients will reduce the oxydative stress induced by iron injections, compared to the one induced in healthy volunteers. It will be an open "proof-of-concept" study aimed at evaluating iron toxicity in critically ill patients (n=40) as compared to healthy volunteers (n=40).

The investigators will compare the oxidative stress (principal judgment criteria= 8-iso-PGF2α) following a 100 mg injection of iron (at T0, T2, T6 and T24 hours post injection) in both groups and the investigators will compare the effect of repeated injections in the critically ill patients.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Ferric Oxide, Saccharated; Iron

Criteria

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