Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
150 participants
INTERVENTIONAL
2006-11-30
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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H
Hydrocortisone
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
P
Treatment by NaCl (placebo)
NaCl
48mL from Day 1 to Day 6
Interventions
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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
NaCl
48mL from Day 1 to Day 6
Eligibility Criteria
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Inclusion Criteria
* 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 adrenocortical insufficiency.
* Treatment by immunosuppressor
* Immunodeficiency.
15 Years
ALL
No
Sponsors
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Serb
UNKNOWN
Nantes University Hospital
OTHER
Responsible Party
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CHu de Nantes
Principal Investigators
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Mahe Joachim, MD
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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CHU Bordeaux
Bordeaux, , France
CHU Morvan de Brest
Brest, , France
CHU Caen
Caen, , France
CH La Roche Sur Yon
La Roche-sur-Yon, , France
Hôtel Dieu
Nantes, , France
CHU Pontchaillou
Rennes, , France
CHU Trousseau
Tours, , France
Countries
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References
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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.
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.
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.
Other Identifiers
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Afssaps: 060785
Identifier Type: -
Identifier Source: secondary_id
CPP: 2006/25
Identifier Type: -
Identifier Source: secondary_id
BRD 06/6-L
Identifier Type: -
Identifier Source: org_study_id
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