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Treatment of Polytraumatisms With Corticoids (Hypolyte)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00563303
First Posted: November 26, 2007
Last Update Posted: April 23, 2010
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.
Collaborator:
Serb
Information provided by:
Nantes University Hospital
  Purpose
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 Intervention Phase
Polytraumatism Drug: hydrocortisone Drug: NaCl Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

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

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

Enrollment: 150
Study Start Date: November 2006
Study Completion Date: July 2009
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: H
Hydrocortisone
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00563303


Locations
France
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
Serb
Investigators
Principal Investigator: Mahe Joachim, MD CHU de Nantes
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pierre-joachim Mahé, investigator coordinator, CHu de Nantes
ClinicalTrials.gov Identifier: NCT00563303     History of Changes
Other Study ID Numbers: BRD 06/6-L
Afssaps: 060785
CPP: 2006/25
First Submitted: September 26, 2006
First Posted: November 26, 2007
Last Update Posted: April 23, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Multiple Trauma
Wounds and Injuries
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents