Reoxygenation After Cardiac Arrest (REOX Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by The Cooper Health System
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The Cooper Health System
ClinicalTrials.gov Identifier:
NCT01881243
First received: June 17, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted

June 17, 2013
June 17, 2013
June 2013
June 2015   (final data collection date for primary outcome measure)
Plasma isoprostanes/isofurans (mechanistic outcome) [ Time Frame: 0 and 6 hours post-ROSC ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Modified Rankin Scale (mRS) (primary neurological outcome) [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
Same as current
Cognitive testing (primary neuropsychological outcome) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Same as current
 
Reoxygenation After Cardiac Arrest (REOX Study)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

This research will measure biomarkers of oxidative stress (isoprostanes and isofurans) on plasma samples.

Probability Sample

Adult patients resuscitated from cardiac arrest

Cardiac Arrest
Not Provided
Adult patients resuscitated from cardiac arrest
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
133
June 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact: Stephen Trzeciak, MD, MPH 856-342-3342 trzeciak-stephen@cooperhealth.edu
United States
 
NCT01881243
REOX, R01HL112815
No
The Cooper Health System
The Cooper Health System
National Heart, Lung, and Blood Institute (NHLBI)
Study Director: Stephen Trzeciak, MD, MPH The Cooper Health System
The Cooper Health System
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP