Reoxygenation After Cardiac Arrest II (REOX II Study)



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:6/17/2017
Start Date:April 2016
End Date:June 2018
Contact:Stephen Trzeciak, MD, MPH
Email:trzeciak-stephen@cooperhealth.edu
Phone:856-342-3342

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The broad objective of this study is to test the association between hyperoxia exposure
after resuscitation from cardiac arrest and outcome. After obtaining written informed
consent subjects enrolled in REOX II will undergo a rapid faction of inspired oxygen (FiO2)
optimization protocol to prevent exposure to hyperoxia. We will compare outcomes between
subjects enrolled in REOX I (observational study only) and REOX II (intervention: rapid FiO2
optimization protocol). Our overarching hypothesis is that exposure to hyperoxia after
return of spontaneous circulation (ROSC) is associated with increased oxidative stress and
worsened neurological and cognitive outcomes.

Specific Aim 1: Test if initiation of the rapid FiO2 optimization protocol 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 interventional study (FiO2 optimization protocol) 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 (IsoPs) and isofurans (IsoFs)] in the plasma at 0 and 6 hours after ROSC using
gas chromatography negative ion chemical ionization mass spectrometry. We will compare
plasma IsoPs/IsoFs at each time point between subjects enrolled in REOX II (i.e. receive the
study intervention, rapid FiO2 optimization) and REOX I (i.e. do not receive the study
intervention) using t-test or Mann-Whitney U as appropriate with corrections for multiple
comparisons.

Specific Aim 2: Test if initiation of the rapid FiO2 optimization protocol following ROSC
from cardiac arrest is associated with a decrease in neurological disability at hospital
discharge.

Approach: In the study described above, we will determine the Modified Rankin Scale (mRS) at
hospital discharge. We will compare proportions of good neurological outcome [defined as a
mRS ≤ 3] between subjects enrolled in REOX II (i.e. receive the study intervention, rapid
FiO2 optimization) vs. those enrolled in REOX I (i.e. do not receive the study
intervention), using binomial test.

Specific Aim 3: Test if initiation of the rapid FiO2 optimization protocol 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). Among survivors, we will compare the 180-day neuropsychological measures (composite
z-scores for each cognitive domain) between the same two groups using t-test or Mann-Whitney
U as appropriate with corrections for multiple comparisons. We will also compare the
proportions of patients able to return to work between the two groups using binomial test

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
We found this trial at
5
sites
Indianapolis, Indiana 46202
Principal Investigator: Jeffrey A Kline, MD
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Nathan I Shapiro, MD, MPH
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Alan E Jones, MD
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: J. Hope Kilgannon, MD
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Camden, NJ
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Philadelphia, Pennsylvania 19104
Principal Investigator: Benjamin S Abella, MD, MPhil
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Philadelphia, PA
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