Cardiac Arrest Clinical Trial
— REOX IIOfficial title:
Reoxygenation After Cardiac Arrest II (REOX II Study)
Verified date | January 2022 |
Source | The Cooper Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Cooper University Hospital | Camden | New Jersey |
United States | Indiana University/ Methodist Hospital | Indianapolis | Indiana |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
The Cooper Health System | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Composite Neuropsychological Testing Score | 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. | 180 days | |
Primary | Plasma Isofurans (pg/mL)/Isoprostanes (pg/mL) Ratio | Change in the isofurans/isoprostanes ratio between 0 and 6 hours post-ROSC | ||
Secondary | Modified Rankin Scale (mRS) (Primary Neurological Outcome) | 0: No symptoms at all
No significant disability despite symptoms; able to carry out all usual duties and activities Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Moderate disability; requiring some help, but able to walk without assistance Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Severe disability; bedridden, incontinent and requiring constant nursing care and attention Dead |
Upon hospital discharge, on average two weeks |
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