Treatment of Polytraumatisms With Corticoids
Information source: Nantes University Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polytraumatism
Intervention: hydrocortisone (Drug); NaCl (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Nantes University Hospital Official(s) and/or principal investigator(s):
Mahe Joachim, MD, Principal Investigator, Affiliation: CHU de Nantes
Overall contact:
Mahe joachim, MD, Phone: 02 40 08 41 54, Email: joachim.mahe@chu-nantes.fr
Summary
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.
Clinical Details
Official title: Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria
Secondary outcome: Incidence of pulmonar infection, bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc.
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Mahe joachim, MD, Phone: 02 40 08 41 54, Email: joachim.mahe@chu-nantes.fr
CHU Morvan de Brest, Brest 29609, France; Not yet recruiting
ARVIEUX, Charles, MD
ARVIEUX Charles, MD, Principal Investigator
CHU Pontchaillou, Rennes 35033, France; Not yet recruiting
MALLEDANT yannick, Md
MALLEDANT yannick, MD, Principal Investigator
CHU Trousseau, Tours 37044, France; Not yet recruiting
FUSCIARDI jacques, MD
FUSCIARDI jacques, MD, Principal Investigator
Hôtel Dieu, Nantes 44093, France; Recruiting
Roquilly Antoine, CCA
Mahe Joachim, Md, Principal Investigator
Asehnoune Karim, MD, Sub-Investigator
CHU Bordeaux, Bordeaux, France; Recruiting
Laurent MERSON, PH
Laurent MERSON, PH, Principal Investigator
Françoise MASSON, PH, Sub-Investigator
CH La Roche Sur Yon, La Roche Sur Yon, France; Recruiting
Benoît RENARD, PH
Benoît RENARD, PH, Principal Investigator
CHU Caen, Caen, France; Recruiting
S. ALLOUCHE, PH
S. ALLOUCHE, PH, Principal Investigator
Additional Information
Starting date: November 2006
Ending date: November 2008
Last updated: October 17, 2008
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