Reoxygenation After Cardiac Arrest (REOX Study)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Reoxygenation After Cardiac Arrest (REOX Study)|
- Plasma isoprostanes/isofurans (mechanistic outcome) [ Time Frame: 0 and 6 hours post-ROSC ] [ Designated as safety issue: No ]
- Modified Rankin Scale (mRS) (primary neurological outcome) [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
- Cognitive testing (primary neuropsychological outcome) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
This research will measure biomarkers of oxidative stress (isoprostanes and isofurans) on plasma samples.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Adult patients resuscitated from cardiac arrest|
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 cognitive domains (memory, executive function, lexical-semantic, visuoperceptual, and psychomotor). We will perform multivariable analyses to determine if post-ROSC hyperoxia exposure is independently associated with neuropsychological deficits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01881243
|Contact: Stephen Trzeciak, MD, MPHfirstname.lastname@example.org|
|United States, Indiana|
|Indiana University/ Methodist Hospital||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Jeffrey A Kline, MD|
|Principal Investigator: Jeffrey A Kline, MD|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Nathan I Shapiro, MD, MPH|
|Principal Investigator: Nathan I Shapiro, MD, MPH|
|United States, Mississippi|
|University of Mississippi Medical Center||Recruiting|
|Jackson, Mississippi, United States, 39216|
|Contact: Alan E Jones, MD|
|Principal Investigator: Alan E Jones, MD|
|United States, New Jersey|
|Cooper University Hospital||Recruiting|
|Camden, New Jersey, United States, 08103|
|Contact: J. Hope Kilgannon, MD|
|Principal Investigator: J. Hope Kilgannon, MD|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Benjamin S Abella, MD, MPhil|
|Principal Investigator: Benjamin S Abella, MD, MPhil|
|Study Director:||Stephen Trzeciak, MD, MPH||Cooper University Hospital|