Treatment of Polytraumatisms With Corticoids

Polytraumatism Clinical Trial

— Hypolyte  

Official title:

Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563303
• Other study ID #: BRD 06/6-L
• Secondary ID: Afssaps: 060785C
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 26, 2006
• Last updated: April 20, 2010
• Start date: November 2006
• Est. completion date: July 2009

Study information

• Verified date: April 2010
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2009
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Multiple Trauma
• Polytraumatism

Intervention

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
• NaCl
48mL from Day 1 to Day 6

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Serb

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria		28 days	No
Secondary	Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc.		28 days	No
Secondary	Incidence of nosocomial pneumopathy		Day 8	No