Treatment of Polytraumatisms With Corticoids (Hypolyte)

This study has been completed.
Sponsor:
Collaborator:
Serb
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00563303
First received: September 26, 2006
Last updated: April 20, 2010
Last verified: April 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Incidence of nosocomial pneumopathy [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Nantes University Hospital

Additional 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
Study First Received: September 26, 2006
Last Updated: April 20, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 19, 2014