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Reoxygenation After Cardiac Arrest (REOX Study) (REOX)

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ClinicalTrials.gov Identifier: NCT01881243
Recruitment Status : Unknown
Verified December 2015 by The Cooper Health System.
Recruitment status was:  Recruiting
First Posted : June 19, 2013
Last Update Posted : December 15, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
The Cooper Health System

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.

Condition or disease
Cardiac Arrest

Detailed Description:

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 (attention, Wechsler Adult Intelligence Scale-IV-digit span; (2) reasoning, Wechsler Adult Intelligence Scale-IV-similarities; (3) immediate and delayed memory, Wechsler Memory Scale-III-logical memory I and II; (4) verbal fluency, Controlled Oral Word Association Test; and (5) executive functioning, Hayling Sentence Completion Test). We will perform multivariable analyses to determine if post-ROSC hyperoxia exposure is independently associated with neuropsychological deficits.


Study Type : Observational
Estimated Enrollment : 280 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reoxygenation After Cardiac Arrest (REOX Study)
Study Start Date : June 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources

Group/Cohort
Adult patients resuscitated from cardiac arrest



Primary Outcome Measures :
  1. Plasma isoprostanes/isofurans (mechanistic outcome) [ Time Frame: 0 and 6 hours post-ROSC ]

Secondary Outcome Measures :
  1. Modified Rankin Scale (mRS) (primary neurological outcome) [ Time Frame: hospital discharge ]

Other Outcome Measures:
  1. Cognitive testing (primary neuropsychological outcome) [ Time Frame: 180 days ]

Biospecimen Retention:   Samples Without DNA
This research will measure biomarkers of oxidative stress (isoprostanes and isofurans) on plasma samples.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients resuscitated from cardiac arrest
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881243


Contacts
Contact: Stephen Trzeciak, MD, MPH 856-342-3342 trzeciak-stephen@cooperhealth.edu

Locations
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         
Sponsors and Collaborators
The Cooper Health System
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Director: Stephen Trzeciak, MD, MPH The Cooper Health System

Responsible Party: The Cooper Health System
ClinicalTrials.gov Identifier: NCT01881243     History of Changes
Other Study ID Numbers: REOX
R01HL112815 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by The Cooper Health System:
Cardiac Arrest, Hyperoxia, Ischemia-reperfusion Injury, Reactive Oxygen Species, Oxidative Stress, Neuropsychological Tests

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases