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
  Purpose

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
Cardiac Arrest

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reoxygenation After Cardiac Arrest (REOX Study)

Resource links provided by NLM:


Further study details as provided by The Cooper Health System:

Primary Outcome Measures:
  • Plasma isoprostanes/isofurans (mechanistic outcome) [ Time Frame: 0 and 6 hours post-ROSC ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified Rankin Scale (mRS) (primary neurological outcome) [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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.


Estimated Enrollment: 133
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)
Groups/Cohorts
Adult patients resuscitated from 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 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Director: Stephen Trzeciak, MD, MPH The Cooper Health System
  More Information

No publications provided

Responsible Party: The Cooper Health System
ClinicalTrials.gov Identifier: NCT01881243     History of Changes
Other Study ID Numbers: REOX, R01HL112815
Study First Received: June 17, 2013
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2014