Hyperoxia and Hypertonic Saline in Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 441
- 试验地点
- 1
- 主要终点
- all-cause mortality
研究概览
简要总结
Assessment of the effect of hyperoxia and hypertonic saline on survival in patients with septic shock Hyperoxia and hypertonic saline may have beneficial effects on organ perfusion and oxygenation and may reduce the organ failure occurences. To date, only scarce data are available. Side effects are not well described. Therefore we designed a randomized clinical trial in order to assess the early administration of hypertonic saline and oxygen in the very early beginning of septic shock.
详细描述
The study is designed as factorial 2x2. Patients will be stratified at the randomisation according the presence or absence of Acute Respiratory Distress Syndrome in order to perform a sub group analysis for all outcome criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with less than 6 hours septic shock according criteria of Bone
- •minimal dose of catecholamines at least 0.1 µg/Kg/min
- •patient with mechanical ventilation
- •written informed consent
排除标准
- •age < 18 years
- •pregnancy
- •participation in other trial with the same endpoint
- •absence of registration in french health care system
- •patient protected by law
- •hypernatremia < 130 mmol/l ou > 145 mmol/l
- •patient with P/F < 100 mm Hg with PEEP > 5 cms of water
- •intracranial hypertension
- •patient admitted for cardiac arrest
- •overt cardiac failure
研究组 & 干预措施
hyperoxia and 3% hypertonic saline
Administration of oxygen with FiO2 = 100% during the first 24 hours and after switch oxygen administration to usual care.
Fluid resuscitation if needed with 3% hypertonic saline during 3 days.
干预措施: oxygen and saline (Drug)
hyperoxia and isotonic saline
Administration of oxygen with FiO2 = 100% during the first 24 hours and after switch oxygen administration to usual care.
Fluid resuscitation if needed with isotonic saline during 3 days.
干预措施: oxygen and saline (Drug)
normoxia and 3% hypertonic saline
Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with 3% hypertonic saline during 3 days.
干预措施: oxygen and saline (Drug)
normoxia and isotonic saline
Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with isotonic saline during 3 days.
干预措施: oxygen and saline (Drug)
结局指标
主要结局
all-cause mortality
时间窗: day 28
次要结局
- safety data(day 1 to day 90)
- all-cause mortality(day 90)
- catecholamines free days(day 1 to day 28)
- evolution of organ failures(day 1 to day 28)
- mechanical ventilation free days(day 1 to day 28)