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Corticosteroid Therapy for Glucocorticoid Insufficiency Related to Traumatic Brain Injury (Corti-TC)

N

Nantes University Hospital (NUH)

Status and phase

Completed
Phase 3

Conditions

Traumatic Brain Injury
Adrenal Insufficiency
Trauma
Pneumonia

Treatments

Drug: Placebo
Drug: Hydrocortisone Fludrocortisone

Study type

Interventional

Funder types

Other

Identifiers

NCT01093261
BRD/10/01-L
SFAR (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

336 patients

Sex

All

Ages

15 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

336 participants in 3 patient groups, including a placebo group

Hydrocortisone and fludrocortisone
Experimental group
Description:
Patients with glucocorticoid insufficiency
Treatment:
Drug: Hydrocortisone Fludrocortisone
Placebo
Placebo Comparator group
Description:
Patients with glucocorticoid insufficiency
Treatment:
Drug: Placebo
Controlled
No Intervention group
Description:
Adapted glucocorticoid function

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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