Centre Hospitalier Universitaire de Nantes, Service d'anesthésie réanimation chirurgicale, Hôtel Dieu-HME, Nantes, France.
Trials. 2011 Oct 14;12:228. doi: 10.1186/1745-6215-12-228.
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.
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.
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.
NCT01093261.
创伤性脑损伤（TBI）是年轻患者严重长期残疾的主要原因。医院获得性肺炎（HAP）增加了创伤性脑损伤患者的发病率和死亡率。在一项研究中，皮质激素治疗多发伤患者创伤性皮质激素不足（CI）可预防 HAP，特别是在严重 TBI 亚组患者中。氟氢可的松推荐用于患有急性蛛网膜下腔出血的严重脑损伤患者。皮质激素与氟氢可的松联合是否能预防 HAP 并改善神经恢复尚不确定。本研究旨在比较皮质激素治疗与安慰剂对 CI 的 TBI 患者的疗效。
CORTI-TC（创伤性脑损伤患者皮质激素治疗）试验是一项多中心、随机、安慰剂对照、双盲、双臂研究。376 名因严重创伤性脑损伤（格拉斯哥昏迷量表≤8）入住重症监护病房的患者在创伤后 24 小时内随机分为两组：一组接受氢化可的松（200mg·d-1，持续 7 天，第 8-9 天 100mg，第 10 天 50mg）和氟氢可的松（50μg，持续 10 天）治疗；另一组接受安慰剂治疗。如果患者出现适当的肾上腺反应，则停止治疗。主要终点为第 28 天 HAP。辅助研究的终点为 6 个月和 12 个月时的神经状态。
CORTI-TC 试验是第一个随机对照试验，旨在研究 CI 的 TBI 患者接受氢化可的松联合氟氢可的松治疗是否能预防 HAP 并改善长期恢复。
NCT01093261。
