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Treatment of Polytraumatisms With Corticoids (Hypolyte)

Primary Purpose

Polytraumatism

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
hydrocortisone
NaCl
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polytraumatism

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Bordeaux
  • CHU Morvan de Brest
  • CHU Caen
  • CH La Roche Sur Yon
  • Hôtel Dieu
  • CHU Pontchaillou
  • CHU Trousseau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

H

P

Arm Description

Hydrocortisone

Treatment by NaCl (placebo)

Outcomes

Primary Outcome Measures

Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria

Secondary Outcome Measures

Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc.
Incidence of nosocomial pneumopathy

Full Information

First Posted
September 26, 2006
Last Updated
April 20, 2010
Sponsor
Nantes University Hospital
Collaborators
Serb
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1. Study Identification

Unique Protocol Identification Number
NCT00563303
Brief Title
Treatment of Polytraumatisms With Corticoids
Acronym
Hypolyte
Official Title
Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nantes University Hospital
Collaborators
Serb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polytraumatism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H
Arm Type
Experimental
Arm Description
Hydrocortisone
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
Treatment by NaCl (placebo)
Intervention Type
Drug
Intervention Name(s)
hydrocortisone
Intervention Description
200mg/jour (solution of 48mL), Day 1 to Day 4 100mg/jour (solution of 48mL), Day 5 50mg/jour (solution of 48mL), Day 6
Intervention Type
Drug
Intervention Name(s)
NaCl
Intervention Description
48mL from Day 1 to Day 6
Primary Outcome Measure Information:
Title
Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc.
Time Frame
28 days
Title
Incidence of nosocomial pneumopathy
Time Frame
Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahe Joachim, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Facility Name
CHU Morvan de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU Caen
City
Caen
Country
France
Facility Name
CH La Roche Sur Yon
City
La Roche Sur Yon
Country
France
Facility Name
Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23450051
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.
Results Reference
derived
PubMed Identifier
22777514
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.
Results Reference
derived
PubMed Identifier
21427372
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.
Results Reference
derived

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Treatment of Polytraumatisms With Corticoids

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