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

NCT01443624 | Completed DMC

• 2 other identifiers: P1011042011-000819-10
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Critical Illness

Keywords

iron; critical illness; oxidative stress

Outcome Measures

Primary Outcomes (4)

• serum 8-iso-PGF2α

  oxidative stress

  0 hours

• serum 8-iso-PGF2α

  oxidative stress

  2 hours

• serum 8-iso-PGF2α

  oxidative stress

  6 hours

• serum 8-iso-PGF2α

  oxidative stress

  24 hours

Secondary Outcomes (4)

• Advanced Oxidized Protein Product

  0 hours

• Advanced Oxidized Protein Product

  2 hours

• Advanced Oxidized Protein Product

  6 hours

• Advanced Oxidized Protein Product

  24 hours

Study Arms (1)

critical care patients venofer

EXPERIMENTAL

Critically ill patients are injected with Venofer (ferric hydroxide sucrose) 100mg IV in one hour (in critically ill patients the injection could be repeated on day 2 (200mg) and 4 (100mg) depending on treatment

Drug: critical care patients venofer

Interventions

critical care patients venofer DRUG

100mg IV in one hour (in critically ill patients the injection could be repeated on day 2 (200mg) and 4 (100mg) depending on treatment

Also known as: iron (ferric hydroxide sucrose) injection

critical care patients venofer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHU Bichat-Claude Bernard

Paris, 75018, France

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Iron; Injections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Sigismond Lasocki, MD PhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: September 30, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 14, 2013

Record last verified: 2013-08

Locations

FR (1)