title: Corticotherapy for traumatic brain-injured patients--the Corti-TC trial: study protocol for a randomized controlled trial.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT01093261.
authors: Centre Hospitalier Universitaire de Nantes, Service d'anesthésie réanimation chirurgicale, Hôtel Dieu-HME, Nantes, France. karim.asehnoune@chu-nantes.fr
authors: Karim
authors: K
authors: Asehnoune
authors: Antoine
authors: A
authors: Roquilly
authors: Véronique
authors: V
authors: Sebille
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001930:Brain Injuries / Q000188:drug therapy*; D002985:Clinical Protocols; D003428:Cross Infection / Q000209:etiology; D004311:Double-Blind Method; D005438:Fludrocortisone / Q000627:therapeutic use*; D006801:Humans; D006854:Hydrocortisone / Q000627:therapeutic use*; D007362:Intensive Care Units; D008875:Middle Aged; D011014:Pneumonia / Q000209:etiology
chemical_list: D005438:Fludrocortisone; D006854:Hydrocortisone