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Treatment of Polytraumatisms With Corticoids (Hypolyte)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00563303
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : April 23, 2010
Information provided by:
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Polytraumatism Drug: hydrocortisone Drug: NaCl Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency
Study Start Date : November 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: H
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

Placebo Comparator: P
Treatment by NaCl (placebo)
Drug: NaCl
48mL from Day 1 to Day 6

Primary Outcome Measures :
  1. Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc. [ Time Frame: 28 days ]
  2. Incidence of nosocomial pneumopathy [ Time Frame: Day 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00563303

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CHU Bordeaux
Bordeaux, France
CHU Morvan de Brest
Brest, France, 29609
CHU Caen
Caen, France
CH La Roche Sur Yon
La Roche Sur Yon, France
Hôtel Dieu
Nantes, France, 44093
CHU Pontchaillou
Rennes, France, 35033
CHU Trousseau
Tours, France, 37044
Sponsors and Collaborators
Nantes University Hospital
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Principal Investigator: Mahe Joachim, MD CHU de Nantes
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pierre-joachim Mahé, investigator coordinator, CHu de Nantes Identifier: NCT00563303    
Other Study ID Numbers: BRD 06/6-L
Afssaps: 060785
CPP: 2006/25
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: April 23, 2010
Last Verified: April 2010
Additional relevant MeSH terms:
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Multiple Trauma
Wounds and Injuries
Anti-Inflammatory Agents