Reoxygenation After Cardiac Arrest II (REOX II Study) (REOX II)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02698826|
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : June 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest||Other: Protocol for rapid FiO2 optimization||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reoxygenation After Cardiac Arrest II (REOX II Study)|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: Adult patients resuscitated from cardiac arrest
Rapid FiO2 optimization protocol
Other: Protocol for rapid FiO2 optimization
We plan to test a protocol for FiO2 optimization for mechanically ventilated post-cardiac arrest subjects, with a therapeutic goal of partial pressure of arterial oxygen (PaO2) of 60-99 mmHg, based on the PaO2 range that was associated with the lowest risk of poor outcome in our previously published work. We also use PaO2 (measured by arterial blood gas [ABG] analysis) as the ultimate goal rather than arterial oxygen saturation (SaO2) measured by pulse oximetry because an SaO2 value <100% on pulse oximetry monitoring does not always exclude supranormal PaO2. The protocol in this application begins with very rapid reduction of FiO2 as much as possible according to SaO2 values, and when FiO2 is maximally reduced by SaO2 an ABG is measured, followed by finer adjustment of FiO2 to achieve a PaO2 60-99 mmHg. The protocol not only prescribes each downward titration of FiO2 but it also includes detailed limbs for upward titration of FiO2 to account for potential "overshoot" in FiO2 reduction.
- Plasma isofurans (pg/mL)/isoprostanes (pg/mL) ratio [ Time Frame: Change in the isofurans/isoprostanes ratio between 0 and 6 hours post-ROSC ]
- Modified Rankin Scale (mRS) (primary neurological outcome) [ Time Frame: Upon hospital discharge, on average two weeks ]
- Composite neuropsychological testing score [ Time Frame: 180 days ]The neuropsychological testing uses validated instruments across five cognitive domains: (1) 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698826
|Contact: Stephen Trzeciak, MD, MPHfirstname.lastname@example.org|
|United States, Indiana|
|Indiana University/ Methodist Hospital||Not yet 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||Not yet 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||Not yet 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||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Benjamin S Abella, MD, MPhil|
|Principal Investigator: Benjamin S Abella, MD, MPhil|
|Study Director:||Stephen Trzeciak, MD, MPH||The Cooper Health System|