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Evaluation of Oxidative Stress Induced by Iron Injection in Healthy Volunteers Versus Critical Care Patients (SOFI)
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.
Details
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 80 |
| Start date | 2011-10 |
| Completion | 2013-08 |
Conditions
- Critical Illness
Interventions
- critical care patients venofer
Primary outcomes
- serum 8-iso-PGF2α — 0 hours
oxidative stress - serum 8-iso-PGF2α — 2 hours
oxidative stress - serum 8-iso-PGF2α — 6 hours
oxidative stress - serum 8-iso-PGF2α — 24 hours
oxidative stress
Countries
France