Effect of Early 48-hour Sevoflurane Inhalation on Gas Exchange and Inflammation in Patients Presenting With Acute Respiratory Distress Syndrome (ARDS) : a Monocentric, Prospective, Randomized Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- PaO2/FiO2 ratio
研究概览
简要总结
Numerous trials support the efficacy and safety of volatile anesthetic agents, namely inhalation of sevoflurane through dedicated devices, for the sedation of ICU patients. Several preclinical studies have shown that sevoflurane inhalation improves gas exchange and decreases pulmonary and systemic inflammation in experimental models of acute respiratory distress syndrome (ARDS).
The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of an early 48-hour sevoflurane inhalation on gas exchange and inflammation in patients with ARDS.
详细描述
BACKGROUND:
Acute respiratory distress syndrome (ARDS) is characterized by hypoxemic respiratory failure that can be lethal in 30 to 60% of patients. Its pathophysiological landmark, diffuse alveolar damage, is associated with alveolar inflammation, epithelial injury and alveolar fluid clairance impairment.
Several preclinical studies have shown that early sevoflurane inhalation improves gas exchange, reduces alveolar edema and attenuates pulmonary and systemic inflammation in experimental models of ARDS.
To date, no clinical trial has assessed the effects of early sevoflurane inhalation in ARDS patients.
DESIGN NARRATIVE:
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with criteria for moderate to severe ARDS since less than 24 hours (
- •Informed consent
排除标准
- •Suspected or proven intracranial hypertension
- •Midazolam, sevoflurane or cisatracurium allergy
- •Medical history of malignant hyperthermia
- •Severe liver failure
- •Chemotherapy treatment in the last month
- •Severe neutropenia (< 0.5 G/l)
研究组 & 干预措施
conventional group
a "conventional group", in which intravenous sedation with midazolam will be administered
干预措施: midazolam (Drug)
sevoflurane group
a "sevoflurane group", in which patients will inhale sevoflurane during a 48 hour-period, through dedicated devices
干预措施: sevoflurane (Drug)
结局指标
主要结局
PaO2/FiO2 ratio
时间窗: at 48 hours
次要结局
- Duration of controlled mechanical ventilation(at day 30)
- Number of ventilatory-free days(at day 30)
- Number of organ failure-free days(at day 30)
- Plasma and alveolar levels of sRAGE(at 48 hours)
- Pulmonary static compliance, resistance and elastance(at day 1, day 2)
- Total duration of mechanical ventilation (controlled/assisted)(at day 30)
- Lowest PaO2/FiO2 during the first 5 days of the study(at 5 days)
- Vasopressor requirements(at 48 hours)
- Mortality(at day 30)
- - Plasma and alveolar levels of proinflammatory cytokines : tumor necrosis factor alpha (TNFα, interleukin (IL)-1β, IL-6, IL-8(at 48 hours)
- PaO2/FiO2 ratio(at day 1, day 3, day 5)
- Mean PaO2/FiO2 ratio during the first 5 days of the study(at 5 days)