Official Title: “Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency”

Interest of treatment of polytraumatisms with corticoids (hydrocortisone) for patient with relative adrenocortical insufficiency on frequency of nosocomial infection, and hemodynamic complications and organs injuries.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2006

Intervention(s) in this Clinical Trial

• Drug: hydrocortisone
  • 200mg/jour (solution of 48mL), Day 1 to Day 4 100mg/jour (solution of 48mL), Day 5 50mg/jour (solution of 48mL), Day 6
• Drug: NaCl
  • 48mL from Day 1 to Day 6

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: H
  • Hydrocortisone
• Placebo Comparator: P
  • Treatment by NaCl (placebo)

Primary Measures

• Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria
  • Time Frame: 28 days
    Safety Issue?: No

Secondary Measures

• Incidence of pulmonar infection, bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc.
  • Time Frame: 28 days
    Safety Issue?: No

Inclusion Criteria:

• Age superior of 15 years
• Hospitalization inréanimation for polytraumatism (lesion of two organs with a vital risk)
• SISS score more than 15
• Intubation for more than 48 hours.
• Agreement of a family member
• Patient with insurance

Exclusion Criteria:

• History of corticothérapie within 6 months
• History of adrenocortical insufficiency.
• Treatment by immunosuppressor
• Immunodeficiency.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Nantes University Hospital

Overall Clinical Trial Officials and Contacts

Mahe Joachim, MD Principal Investigator CHU de Nantes  

Overall Contact: Mahe joachim, MD 02 40 08 41 54 joachim.mahe@chu-nantes.fr

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00563303

Study ID Number: BRD 06/6-L

ClinicalTrials.gov Identifier: NCT00563303

Health Authority: France: Afssaps - French Health Products Safety Agency