Reoxygenation After Cardiac Arrest (REOX Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 5
- 主要终点
- Plasma isoprostanes/isofurans (mechanistic outcome)
研究概览
简要总结
The broad objective of this study is to test the association between hyperoxia exposure after resuscitation from cardiac arrest and outcome. Our overarching hypothesis is that hyperoxia after ROSC is associated with increased oxidative stress and worsened neurological and cognitive outcomes.
详细描述
Specific Aim 1: Test if the degree and duration of hyperoxia following ROSC from cardiac arrest is associated with the degree of in vivo oxidative stress during the post-resuscitation phase of therapy.
Approach: We will conduct a multicenter prospective observational study of adult patients resuscitated from cardiac arrest. We will record data pertaining to oxygenation parameters and other factors and measure biomarkers of oxidative stress (isoprostanes and isofurans) in the plasma at 0 and 6 hours after ROSC using gas chromatography negative ion chemical ionization mass spectrometry. We will determine the exposure to post-ROSC hyperoxia by calculating the time-weighted average PaO2 and SaO2 for the post-resuscitation phase of therapy, and will test the association with plasma isoprostane and isofuran levels.
Specific Aim 2: Test if the degree and duration of hyperoxia following ROSC from cardiac arrest is associated with the degree of neurological disability at hospital discharge.
Approach: In the study described above, we will determine the Modified Rankin Scale at hospital discharge. We will perform multivariable analyses adjusted for numerous covariates known to be associated with outcome in post-cardiac arrest patients to determine if post-ROSC hyperoxia exposure is independently associated with neurological disability.
Specific Aim 3: Test if the degree and duration of hyperoxia following ROSC from cardiac arrest is associated with neuropsychological outcomes among survivors at 180 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age >17 years
- •Cardiac arrest
- •Return of spontaneous circulation
- •Not following commands immediately after ROSC
- •Endotracheal intubation
- •Clinician intent to treat with therapeutic hypothermia (or absence of clinician intent to withhold therapeutic hypothermia)
排除标准
- •Presumed etiology of arrest is trauma
- •Presumed etiology of arrest is hemorrhage
- •Presumed etiology of arrest is sepsis
- •Permanent resident of nursing home or other long-term care facility
- •Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end stage chronic illness with no reasonable expectation of survival to hospital discharge
结局指标
主要结局
Plasma isoprostanes/isofurans (mechanistic outcome)
时间窗: 0 and 6 hours post-ROSC
次要结局
- Modified Rankin Scale (mRS) (primary neurological outcome)(hospital discharge)