Opothérapie Par Hydrocortisone après Injection Unique d'Etomidate Chez le Patient de réanimation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- diminution of 50% of the proportion of patients with a score SOFA of 3 or 4
研究概览
简要总结
the objective of the study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate
详细描述
Etomidate is a hypnotic widely used for patients in intensive care who require rapid induction, because of its short duration of action, its excellent cardiovascular tolerance and maintenance of cerebral perfusion pressure.
For this reason etomidate remains the hypnotic of choice for induction of unstable patients. Other hypnotics currently in existence do not provide adequate safety with a sufficiently predictable and stable effect in this situation. However, it may induce acute adrenal insufficiency by inhibition of 11-b-hydroxylase necessary for the synthesis of cortisol from compound S. An observational study conducted at the Grenoble University hospital in 2006 showed that the duration of this blockage can reach up to 48 hours. Acute adrenal insufficiency in intensive care patients is associated with a poor prognosis. The main objective of this study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate.
This is an interventional, prospective, randomized, placebo-controlled, double-blind, analytical study with a cohort of 100 patients between 18 and 80 years, of both sexes, who have had tracheal intubation in a pre-hospital or shock treatment setting with the administration of a single injection of etomidate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received an unique injection of etomidate in pre-hospital situation or at "déchocage" in the previous 6 hours.
- •informed consent signed by the patient or the reliable person
- •affiliation to a regime of social security
排除标准
- •persons aimed at the articles L. 1121-5 à L. 1121-8 of the french code of public health
- •toxic shock requiring a treatment by HSHC inn accordance with the criteria of Annane et Al. [13]
- •purpura fulminans
- •chronicle suprarenal insufficiency
- •patients likely to present an acute suprarenal insufficiency : current treatment with antifungal : ketoconazole or fluconazole, known HIV infection, Sheehan syndrome
- •corticotherapy in the 6 last months
- •initiation of hydrocortisone therapy out of the study
- •survival estimated at less than 48 hours
- •no benefits of social security
- •refusal to participate by patient or reliable person
研究组 & 干预措施
1
Hydrocortisone
干预措施: Hydrocortisone (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
diminution of 50% of the proportion of patients with a score SOFA of 3 or 4
时间窗: 12h, 24h and 48h after the injection of hydrocortisone
mean arterial blood pressure
时间窗: during the hospitalisation
plasmatic cortisol and substance S before and after ACTH stimulation
时间窗: h-4; h6; h12 and h24
次要结局
- clinical state(12h and 24h)
- hospitalisation duration in reanimation(until day28)
- duration of mechanical ventilation(until day28)
- duration and posology of adrenaline and noradrenaline(h0, h4, h6, h12, h24 and h48)
- complications during hospitalization in reanimation potentially due to HSHC(until day28)
- dose of etomidate injection(h0)
- mortality(day28)