Treatment of Polytraumatisms With Corticoids (Hypolyte)

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Polytraumatism

Treatments: Drug: hydrocortisone; Drug: NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT00563303

BRD 06/6-L

CPP: 2006/25

Afssaps: 060785

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 15+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

H

Experimental group

Description:

Hydrocortisone

Treatment:

Drug: hydrocortisone

P

Placebo Comparator group

Description:

Treatment by NaCl (placebo)

Treatment:

Drug: NaCl