Corticosteroid Therapy for Glucocorticoid Insufficiency Related to Traumatic Brain Injury

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborator: Société Française d'Anesthésie et de Réanimation
• Treatments: Cortisol succinate; Fludrocortisone; Glucocorticoids; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

• Trauma brain injury (Glasgow score below 8 and lesion on scanner)

• Informed consent

• Time to inclusion inferior to 24 hours

Exclusion Criteria:

• Tetraplegia

• Administration of chronic corticosteroids in the last 6 months or acute steroid therapy (any dose) within 4 weeks (excluding inhaled steroids). Topical steroids are not exclusions

• Drug-induced immunosuppression, including chemotherapy or radiation therapy within 4 weeks before the study

• Antibiotherapy for active sepsis at the time of inclusion