Clinical Trial: Reoxygenation After Cardiac Arrest (REOX Study)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Reoxygenation After Cardiac Arrest (REOX Study)
Brief Summary: 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.
Detailed Summary:
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.
Approach: In the study described above, we will assess neuropsychological outcome among survivors at 180 days. Neuropsychological testing will use validated instruments across five cogn
Sponsor: The Cooper Health System
Current Primary Outcome: Plasma isoprostanes/isofurans (mechanistic outcome) [ Time Frame: 0 and 6 hours post-ROSC ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Modified Rankin Scale (mRS) (primary neurological outcome) [ Time Frame: hospital discharge ]
Original Secondary Outcome: Same as current
Information By: The Cooper Health System
Dates:
Date Received: June 17, 2013
Date Started: June 2013
Date Completion: June 2017
Last Updated: December 11, 2015
Last Verified: December 2015
