Related Experiment Video
Updated: May 19, 2026
Controlled Cortical Impact Model for Traumatic Brain Injury
Published on: August 5, 2014
Corticotherapy for traumatic brain-injured patients--the Corti-TC trial: study protocol for a randomized controlled
Karim Asehnoune1, Antoine Roquilly, Véronique Sebille
1Centre Hospitalier Universitaire de Nantes, Service d'anesthésie réanimation chirurgicale, Hôtel Dieu-HME, Nantes, France. karim.asehnoune@chu-nantes.fr
Insights
This study investigated if hydrocortisone and fludrocortisone prevent hospital-acquired pneumonia and improve neurological recovery in severe traumatic brain injury (TBI) patients with corticosteroid insufficiency (CI). Results are pending but this trial is the first to assess this combination therapy.
Area of Science:
- Neuroscience
- Critical Care Medicine
- Endocrinology
Background:
- Traumatic brain injury (TBI) is a leading cause of disability in young individuals.
- Hospital-acquired pneumonia (HAP) increases morbidity and mortality in TBI patients.
- Corticosteroid insufficiency (CI) is common in TBI, and hydrocortisone has shown potential in preventing HAP.
Purpose of the Study:
- To evaluate the efficacy of corticotherapy (hydrocortisone with fludrocortisone) versus placebo in preventing HAP in severe TBI patients with CI.
- To assess the impact of this combination therapy on long-term neurological recovery.
Main Methods:
- The CORTI-TC trial is a multicenter, randomized, double-blind, placebo-controlled study.
- 376 severe TBI patients (Glasgow Coma Scale ≤ 8) received hydrocortisone/fludrocortisone or placebo within 24 hours of trauma.
- Primary endpoint: HAP at day-28. Secondary endpoint: Neurological status at 6 and 12 months.
Main Results:
- Data on HAP incidence and neurological outcomes at 6 and 12 months are being collected.
- The study is powered to detect significant differences between the treatment and placebo groups.
Conclusions:
- The CORTI-TC trial is the first randomized controlled trial designed to determine if hydrocortisone with fludrocortisone can prevent HAP and improve neurological recovery in TBI patients with CI.
- Findings will inform clinical practice regarding the use of corticotherapy in this patient population.
Background:
Traumatic brain injury (TBI) is a main cause of severe prolonged disability of young patients. Hospital acquired pneumonia (HAP) add to the morbidity and mortality of traumatic brain-injured patients. In one study, hydrocortisone for treatment of traumatic-induced corticosteroid insufficiency (CI) in multiple injured patients has prevented HAP, particularly in the sub-group of patients with severe TBI. Fludrocortisone is recommended in severe brain-injured patients suffering from acute subarachnoid hemorrhage. Whether an association of hydrocortisone with fludrocortisone protects from HAP and improves neurological recovery is uncertain. The aim of the current study is to compare corticotherapy to placebo for TBI patients with CI.
Methods:
The CORTI-TC (Corticotherapy in traumatic brain-injured patients) trial is a multicenter, randomized, placebo controlled, double-blind, two-arms study. Three hundred and seventy six patients hospitalized in Intensive Care Unit with a severe traumatic brain injury (Glasgow Coma Scale ≤ 8) are randomized in the first 24 hours following trauma to hydrocortisone (200 mg.day-1 for 7 days, 100 mg on days 8-9 and 50 mg on day-10) with fludrocortisone (50 μg for 10 days) or double placebo. The treatment is stopped if patients have an appropriate adrenal response. The primary endpoint is HAP on day-28. The endpoint of the ancillary study is the neurological status on 6 and 12 months.
Discussion:
The CORTI-TC trial is the first randomized controlled trial powered to investigate whether hydrocortisone with fludrocortisone in TBI patients with CI prevent HAP and improve long term recovery.
Trial Registration:
NCT01093261.
