Trial Outcomes & Findings for Reoxygenation After Cardiac Arrest II (REOX II Study) (NCT NCT02698826)
NCT ID: NCT02698826
Last Updated: 2022-03-29
Results Overview
COMPLETED
PHASE1
16 participants
Change in the isofurans/isoprostanes ratio between 0 and 6 hours post-ROSC
2022-03-29
Participant Flow
Participant milestones
| Measure |
Adult Patients Resuscitated From Cardiac Arrest
Rapid FiO2 optimization protocol
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.
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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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2
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Overall Study
NOT COMPLETED
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14
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Reasons for withdrawal
| Measure |
Adult Patients Resuscitated From Cardiac Arrest
Rapid FiO2 optimization protocol
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.
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|---|---|
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Overall Study
Death
|
13
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Overall Study
Adverse Event
|
1
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Baseline Characteristics
Reoxygenation After Cardiac Arrest II (REOX II Study)
Baseline characteristics by cohort
| Measure |
FiO2 Titration Group
n=16 Participants
Rapid FiO2 optimization protocol 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.
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|---|---|
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Age, Continuous
|
55 years
STANDARD_DEVIATION 18 • n=99 Participants
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Sex: Female, Male
Female
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7 Participants
n=99 Participants
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Sex: Female, Male
Male
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9 Participants
n=99 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Black or African American
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3 Participants
n=99 Participants
|
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Race (NIH/OMB)
White
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13 Participants
n=99 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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16 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Change in the isofurans/isoprostanes ratio between 0 and 6 hours post-ROSCPopulation: Not analyzed secondary to no measurements obtained for intervention arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Upon hospital discharge, on average two weeks0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Outcome measures
| Measure |
FiO2 Titration
n=16 Participants
Not analyzed secondary to insufficient samples
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|---|---|
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Modified Rankin Scale (mRS) (Primary Neurological Outcome)
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6 score on a scale
Interval 0.0 to 6.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 180 daysPopulation: No analysis performed secondary to no patients were able to undergo the neuropsychological testing.
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.
Outcome measures
Outcome data not reported
Adverse Events
FiO2 Titration
Serious adverse events
| Measure |
FiO2 Titration
n=16 participants at risk
Single arm
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|---|---|
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Cardiac disorders
Death
|
81.2%
13/16 • Number of events 13 • 1.5 years
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Nervous system disorders
Poor neurological outcome
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6.2%
1/16 • Number of events 1 • 1.5 years
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Other adverse events
Adverse event data not reported
Additional Information
Brian Roberts, MD/ REOX Study Director
Cooper University Health Care
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place