Reoxygenation After Cardiac Arrest (REOX Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reoxygenation After Cardiac Arrest II (REOX II Study)

NCT02698826

Cardiac Arrest

COMPLETED PHASE1

Hyperoxia Before and After Cardiac Arrest and Myocardial Damage

NCT03571074

Cardiac Arrest

COMPLETED

REmote COnditioning in Out-of-Hospital Cardiac Arrest

NCT06306625

Out-Of-Hospital Cardiac Arrest

RECRUITING NA

Brain Oxygenation During Cardiopulmonary Resuscitation

NCT03464123

Cardiac Arrest, Out-Of-Hospital

COMPLETED

Effect of Remote Ischemic Post-conditioning on Out-of-hospital Cardiac Arrest

NCT03093948

Out-Of-Hospital Cardiac Arrest

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adult patients resuscitated from cardiac arrest

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No