NCT04359862终止4 期
Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection
Fundación para la Investigación del Hospital Clínico de Valencia5 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2020年4月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- PaO2/FiO2
研究概览
简要总结
It is a multicenter, national, randomized 1:1 ratio, controlled, parallel, open study.
Patients with severe ARDS-CoVid19 will be included in the trial within the first 24 hours.
Patients will be randomized to one of the treatment groups:
- SEV group: 25 patients with Sevoflurane sedation by inhalation, starting at 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved (BIS 40-50)
- PRO group: 25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)
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
- •Age 18 years or more.
- •Diagnosis of Acute Respiratory Distress Syndrome caused by COVID19 infection.
- •Signature of Patient's Consent or Verbal Consent of Legal Representative
排除标准
- •Intracranial hypertension
- •Hypersensitivity to the active ingredient (propofol or sevoflurane) or to any of the excipients
- •Current volume < 250ml
- •History of malignant hyperthermia
- •Liver failure
- •Neutropenia (<0.5x109)
- •Pregnant or lactating women
- •Have received chemotherapy in the last month since their inclusion in the study
研究组 & 干预措施
SEVOFLURANE Group
Experimental
干预措施: Sevoflurane (Drug)
PROPOFOL Group
Active Comparator
干预措施: Propofol (Drug)
结局指标
主要结局
PaO2/FiO2
时间窗: Day 2
To evaluate the effect of 48-hour treatment with inhaled sevoflurane on arterial oxygenation, assessed by PaO2/FiO2 on day two, in patients with ARDS-CoVid19
次要结局
- IL-1b(Day 2)
- Mortality(Day 30)
- IL-6(Day 2)
- IL-8(Day 2)
- TNFα(Day 2)
研究者
研究点 (5)
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