Clinical trial: Evaluation of Oxidative Stress Induced by Iron Injection in Healthy Volunteers and Critical Care Patients (NCT01443624)

Eligibility 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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 90 Years

Patient description (medical language): A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug.  Blood pressure is 120/80 mm Hg and pulse is 70/min.  Oxygen saturation is 99% on room air.  BMI is 24 kg/m2.  Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis.

Patient description (patient's own words): I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550  μg/L. The doctor diagnosed me with iron overload.

Does the patient match the trial criteria? Contradiction