Clinical trial NCT00563303: Treatment of Polytraumatisms With Corticoids
Official title: Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Polytraumatism
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Serb
First posted: 2007-11-26
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc.
timeFrame: 28 days
measure: Incidence of nosocomial pneumopathy
timeFrame: Day 8
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: CHU Morvan de Brest
city: Caen
country: France
facility: CHU Caen
city: La Roche Sur Yon
country: France
facility: CH La Roche Sur Yon
city: Nantes
country: France
facility: Hôtel Dieu
city: Rennes
country: France
facility: CHU Pontchaillou
city: Tours
country: France
facility: CHU Trousseau
Study officials:
affiliation: Nantes University Hospital
name: Mahe Joachim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Bras M, Roquilly A, Deckert V, Langhi C, Feuillet F, Sebille V, Mahe PJ, Bach K, Masson D, Lagrost L, Costet P, Asehnoune K, Cariou B. Plasma PCSK9 is a late biomarker of severity in patients with severe trauma injury. J Clin Endocrinol Metab. 2013 Apr;98(4):E732-6. doi: 10.1210/jc.2012-4236. Epub 2013 Feb 28.
citation: Asehnoune K, Mahe PJ, Seguin P, Jaber S, Jung B, Guitton C, Chatel-Josse N, Subileau A, Tellier AC, Masson F, Renard B, Malledant Y, Lejus C, Volteau C, Sebille V, Roquilly A. Etomidate increases susceptibility to pneumonia in trauma patients. Intensive Care Med. 2012 Oct;38(10):1673-82. doi: 10.1007/s00134-012-2619-8. Epub 2012 Jul 10.
citation: Roquilly A, Mahe PJ, Seguin P, Guitton C, Floch H, Tellier AC, Merson L, Renard B, Malledant Y, Flet L, Sebille V, Volteau C, Masson D, Nguyen JM, Lejus C, Asehnoune K. Hydrocortisone therapy for patients with multiple trauma: the randomized controlled HYPOLYTE study. JAMA. 2011 Mar 23;305(12):1201-9. doi: 10.1001/jama.2011.360.