Corticosteroid Therapy for Glucocorticoid Insufficiency Related to Traumatic Brain Injury

Summary

Traumatic brained injured (TBI) patients frequently suffered from glucocorticoid insufficiency that is associated with a raise in the rate of pneumonia.

In a placebo-controlled, multi-center, double-blinded trial, treatment of glucocorticoid insufficiency (hydrocortisone associated with fludrocortisone) will be assessed for prevention of post trauma pneumonia in a population of severe TBI patients.

Conditions

• Traumatic Brain Injury
• Trauma
• Adrenal Insufficiency
• Pneumonia

Interventions

DRUG

Placebo

Placebo: continuous intra venous infusion of placebo n°1 for 10 days. enteral administration of placebo n°2 for 10 days.

DRUG

Hydrocortisone Fludrocortisone

HYDROCORTISONE: 200 mg.day-1 for 7 days, 100 mg.day-1 on day 8 and 9, 50 mg on day-10 (continuous intravenous infusion) FLUDROCORTISONE: 50 microg.day-1 for 10 days (per os)

Sponsors & Collaborators

• Société Française d'Anesthésie et de Réanimation

  collaborator OTHER

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Karim ASEHNOUNE · Nantes University Hospital

• Antoine ROQUILLY · Nantes University Hospital

• Pierre François Perrigault · CHU de Montpellier

• Pierre Albaladejo · University Hospital, Grenoble

• Marc Leonne · CHU de Marseille

• Olivier Langeron · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2012-11-30

Completion

2012-12-31

Countries

• France

Study Locations