Corticosteroid Therapy for Glucocorticoid Insufficiency Related to Traumatic Brain Injury
Corti-TC
Phase 3 Study of Hydrocortisone and Fludrocortisone in Glucocorticoid Insufficiency Related to Traumatic Brain Injury
2 other identifiers
interventional
336
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2010
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedSeptember 14, 2017
September 1, 2017
2.3 years
March 23, 2010
September 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of hospital acquired pneumonia
Presence of at least two signs (body fever greater than 38°C; leukocytosis greater than 12000/ml or leukopenia below 4000/ml, purulent pulmonary secretions) associated with the appearance of a new infiltrate or modification of an existing infiltrate on chest-X-ray. Confirmation by a lower respiratory tract sample using a quantitative culture with a predefined positive threshold. Hospital-acquired pneumonia was defined as a pneumonia that occurs 48 hours after admission, which was not incubating at time of admission (Am J Respir Crit Care Med 2005; 171, 388-416).
day-28
Secondary Outcomes (10)
Neurological recovery
1-year
other infections
day-28
Organ failures
day-28
Length of ICU stay
6 months
Duration of mechanical ventilation support
6 months
- +5 more secondary outcomes
Study Arms (3)
Hydrocortisone and fludrocortisone
EXPERIMENTALPatients with glucocorticoid insufficiency
Placebo
PLACEBO COMPARATORPatients with glucocorticoid insufficiency
Controlled
NO INTERVENTIONAdapted glucocorticoid function
Interventions
Placebo: continuous intra venous infusion of placebo n°1 for 10 days. enteral administration of placebo n°2 for 10 days.
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)
Eligibility Criteria
You may qualify if:
- Trauma brain injury (Glasgow score below 8 and lesion on scanner)
- Informed consent
You may not qualify if:
- Tetraplegia
- Drug-induced immunosuppression, including chemotherapy or radiation therapy within 4 weeks before the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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
Créteil, 94000, France
University Hospital
Créteil, France
University Hospital
Grenoble, France
University Hospital
Montpellier, France
University Hospital
Nantes, France
University Hospital
Nîmes, 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
Related Publications (2)
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.
PMID: 21999663BACKGROUNDAsehnoune K, Seguin P, Allary J, Feuillet F, Lasocki S, Cook F, Floch H, Chabanne R, Geeraerts T, Roger C, Perrigault PF, Hanouz JL, Lukaszewicz AC, Biais M, Boucheix P, Dahyot-Fizelier C, Capdevila X, Mahe PJ, Le Maguet P, Paugam-Burtz C, Gergaud S, Plaud B, Constantin JM, Malledant Y, Flet L, Sebille V, Roquilly A; Corti-TC Study Group. Hydrocortisone and fludrocortisone for prevention of hospital-acquired pneumonia in patients with severe traumatic brain injury (Corti-TC): a double-blind, multicentre phase 3, randomised placebo-controlled trial. Lancet Respir Med. 2014 Sep;2(9):706-16. doi: 10.1016/S2213-2600(14)70144-4. Epub 2014 Jul 24.
PMID: 25066331DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Karim ASEHNOUNE
Nantes University Hospital
- PRINCIPAL INVESTIGATOR
Antoine ROQUILLY
Nantes University Hospital
- STUDY DIRECTOR
Pierre François Perrigault
CHU de Montpellier
- STUDY DIRECTOR
Pierre Albaladejo
University Hospital, Grenoble
- STUDY DIRECTOR
Marc Leonne
CHU de Marseille
- STUDY DIRECTOR
Olivier Langeron
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asehnoune
Study Record Dates
First Submitted
March 23, 2010
First Posted
March 25, 2010
Study Start
August 1, 2010
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
September 14, 2017
Record last verified: 2017-09