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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT01093261
Date of registration:	23/03/2010
Prospective Registration:	Yes
Primary sponsor:	Nantes University Hospital
Public title:	Corticosteroid Therapy for Glucocorticoid Insufficiency Related to Traumatic Brain Injury Corti-TC
Scientific title:	Phase 3 Study of Hydrocortisone and Fludrocortisone in Glucocorticoid Insufficiency Related to Traumatic Brain Injury
Date of first enrolment:	August 2010
Target sample size:	336
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01093261
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 3

Countries of recruitment
France

Contacts

Name:	Antoine ROQUILLY
Address:
Telephone:
Email:
Affiliation:	Nantes University Hospital

Name:	Pierre Albaladejo
Address:
Telephone:
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Affiliation:	University Hospital, Grenoble

Name:	Olivier Langeron
Address:
Telephone:
Email:
Affiliation:	Assistance Publique - Hôpitaux de Paris

Name:	Pierre François Perrigault
Address:
Telephone:
Email:
Affiliation:	CHU de Montpellier

Name:	Karim ASEHNOUNE
Address:
Telephone:
Email:
Affiliation:	Nantes University Hospital

Name:	Marc Leonne
Address:
Telephone:
Email:
Affiliation:	CHU de Marseille

Key inclusion & exclusion 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

Age minimum: 15 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Traumatic Brain Injury

Adrenal Insufficiency

Pneumonia

Trauma

Intervention(s)

Drug: Placebo

Drug: Hydrocortisone Fludrocortisone

Primary Outcome(s)

rate of hospital acquired pneumonia [Time Frame: day-28]

Secondary Outcome(s)

Organ failures [Time Frame: day-28]

Post traumatic stress disorder [Time Frame: 12 months]

Duration of mechanical ventilation support [Time Frame: 6 months]

other infections [Time Frame: day-28]

Mortality from all causes [Time Frame: day-28]

Neurological recovery [Time Frame: 1-year]

Glucocorticoid function [Time Frame: on day 11-12]

Length of ICU stay [Time Frame: 6 months]

Mortality from all causes [Time Frame: 1 year]

Time to amines withdrawal [Time Frame: day-28]

Secondary ID(s)

BRD/10/01-L

SFAR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Société Française d'Anesthésie et de Réanimation

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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