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Corticosteroid Therapy for Glucocorticoid Insufficiency Related to Traumatic Brain Injury

Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Traumatic Brain Injury; Trauma; Adrenal Insufficiency; Pneumonia

Intervention: Placebo (Drug); Hydrocortisone Fludrocortisone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Nantes University Hospital

Official(s) and/or principal investigator(s):
Karim ASEHNOUNE, Study Chair, Affiliation: Nantes University Hospital
Antoine ROQUILLY, Principal Investigator, Affiliation: Nantes University Hospital
Pierre François Perrigault, Study Director, Affiliation: CHU de Montpellier
Pierre Albaladejo, Study Director, Affiliation: University Hospital, Grenoble
Marc Leonne, Study Director, Affiliation: CHU de Marseille
Olivier Langeron, Study Director, Affiliation: Assistance Publique - Hôpitaux de Paris


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.

Clinical Details

Official title: Phase 3 Study of Hydrocortisone and Fludrocortisone in Glucocorticoid Insufficiency Related to Traumatic Brain Injury

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

Primary outcome: rate of hospital acquired pneumonia

Secondary outcome:

Neurological recovery

other infections

Organ failures

Length of ICU stay

Duration of mechanical ventilation support

Mortality from all causes

Mortality from all causes

Time to amines withdrawal

Post traumatic stress disorder

Glucocorticoid function

Detailed description: Treatment of glucocorticoid insufficiency in TBI patients remains controversial. The purpose of this study is to determine whether hydrocortisone associated with fludrocortisone decreases rate of hospital-acquired pneumonia on day-28 in TBI patients with glucocorticoid insufficiency. Glucocorticoid function will be assessed by a corticotropin test (ACTH 0. 25 mg). The study treatment will be started before reception of the results of these test. Patients with glucocorticoid insufficiency (basal cortisolemia < 15 mcg/dl or post ACTH raise < or = 9 mcg/dl) will be treated for 10 days. Patients with adapted glucocorticoid function will no longer be treated till the results of corticotropin test are known. The primary end point will be rate of HAP on day-28 in patients with glucocorticoid

insufficiency. Secondary endpoints will be neurological recovery (on day-28, - 6 and -12),

mortality (on day-28 and day-365), rate of other infections (on day-28), rate of organ failures (on day-28), mechanical ventilation weaning time, ICU length of stay. In a double-blinded fashion (randomized on a 1: 1 basis), 326 patients receive 200 mg intravenously for 10 days. After 7 days, treatment will be tapered with 100 mg given intravenously for days 8-9, then 50 mg for day 10, and then stopped. All concomitant treatments, including antibiotics, fluids, vasopressors and ancillary therapies will be given at the discretion of the primary care physician. Evidence-based guidelines for the management of severe trauma brain injury (J Neurotrauma 2007; 24 Suppl 1, S1-106.) are encouraged to be followed. All institution are level I trauma center and university hospital. Clinical assessments were performed twice a day in the ICU. When HAP was suspected after clinical examination, a new infiltrate was checked on a chest X-ray. The study protocol stated that antibiotic therapy should not be modified before a bacteriological sample was performed All serious adverse events (SAE) which occur between days 0 and 28, which are unexpected and/or considered possibly or probably related to the study medication, must be documented and reported within 24 hours to the Safety and Efficacy Monitoring Committee. Non-serious adverse events will be listed on the case report form if they are unexpected and believed to be related to the study drug during days 0 to 14. Specific adverse events which will be monitored closely because of their relationship to corticosteroids and trauma are: Use of corticosteroids, i. e. gastrointestinal bleeding and superinfection; hyperglycemia, hypernatremia, muscular weakness, etc. In addition, substudies will include radiological assessment of hypothalamus and hypophyses,immune and neuro-endocrine interactions, post stress disorder assessment.


Minimum age: 15 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

University hospital, Amiens, France

University Hospital, Angers, France

University Hospital, Beaujon, France

University hospital, Bordeaux 33000, France

University Hospital, Brest, France

Universtiy Hospital, Caen, France

University Hospital, Clermont Ferrand, France

University Hospital, Creteil, France

University hospital, Creteil 94000, France

University Hospital, Grenoble, France

University Hospital, Montpellier, France

University Hospital, Nantes, France

University Hospital, Nimes, France

European Hospital Georges Pompidou, Paris 75000, France

Saint Louis Hospital, Paris 75000, France

University hospital, Poitiers 86000, France

University Hospital, Strasbourg, France

University Hospital, Toulouse, France

Additional Information

Related publications:

Asehnoune K, Roquilly A, Sebille V; Corti-TC trial group. Corticotherapy for traumatic brain-injured patients--the Corti-TC trial: study protocol for a randomized controlled trial. Trials. 2011 Oct 14;12:228. doi: 10.1186/1745-6215-12-228.

Starting date: August 2010
Last updated: December 12, 2012

Page last updated: August 23, 2015

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