Treatment of Polytraumatisms With Corticoids

Verified by: Nantes University Hospital, April 2010
First Received: September 26, 2006 | Last Updated: April 20, 2010 | Phase: Phase 2/Phase 3 | Start Date: November 2006
Overall Status: Completed | Estimated Enrollment: 150
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
  • 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)

Outcome Measures for this Clinical Trial

Primary Measures

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

Secondary Measures

  • Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc.
    • Time Frame: 28 days
      Safety Issue?: No
  • Incidence of nosocomial pneumopathy
    • Time Frame: Day 8
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Age superior of 15 years
  • Hospitalization in reanimation 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 corticothérapies 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

Clinical Trial Investigator Information

Lead Investigator: Nantes University Hospital Other

Overall Clinical Trial Officials and Contacts

Mahe Joachim, MD Principal Investigator CHU de Nantes  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00563303