Out-Of-Hospital Cardiac Arrest
Conditions
Brief summary
Ischemia-reperfusion leads to mitochondrial injury, ion-pump injury, cell membrane damage, cytotoxic edema, and excessive oxygen free radical formation, and eventually destroys cells. Cardiac arrest is an example of global ischemia; after spontaneous circulation is restored, ischemia-reperfusion injury develops in cardiac arrest survivors. Remote ischemic postconditioning (RIPoC) involves the application of brief, reversible episodes of ischemia and reperfusion to a vascular bed or tissue, rendering remote tissues and organs resistant to ischemia-reperfusion injury. Accordingly, RIPoC has been suggested as adjunctive therapy to mitigate ischemia-reperfusion injury. RIPoC applied by repeated brief inflation-deflation of a blood pressure cuff protects against myocardial injury, and has been proven effective in acute myocardial infarction. This study aims to perform a randomized controlled trial to determine whether RIPoC has a neuroprotective effect and aids in myocardial recovery in out-of-hospital cardiac arrest patients after restoration of spontaneous circulation. Neuron-specific enolase (NSE) at 48 hours after restoration of spontaneous circulation will be measured as a primary outcome.
Interventions
PROCEDURERemote ischemic post-conditioning
Remote ischemic post-conditioning will undergo in both thighs at the beginning of targeted temperature management. This will be done with noninvasive measurement of blood pressure, with cuffs inflated to 200 mmHg for four 5 min cycles and interrupted three times for 5 min with cuff deflation.
Sponsors
Chonnam National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (19 years and older) * comatose out-of-hospital cardiac arrest with sustained restoration of spontaneous circulation * Undergoing targeted temperature management * Time of enrollment ≤ 6hrs from restoration of spontaneous circulation * cardiac arrest from medical cause (cardiac or other medical cause)
Exclusion criteria
* Pre-existing dementia, brain injury, or dependence on others (cerebral performance category scale greater than 3) * Traumatic etiology for cardiac arrest * Protected population (pregnant, prisoner) * in-hospital cardiac arrest * Known bleeding diathesis * suspected or confirmed acute intracranial hemorrhage * suspected or confirmed acute ischemic stroke * Known limitations in therapy and do-not-resuscitate order * known disease making 180-day survival unlikely * \>6 hours from restoration of spontaneous circulation to randomization * cardiac arrest from asphyxia (hanging, foreign body airway obstruction), drowning, drug overdose, or electrocution * peripheral vascular disease (Deep vein thrombosis, arteriosclerosis obliterans) * systolic blood pressure \< 80 mmHg in spite of fluid loading/vasopressor and/or inotropic medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| neuron specific enolase | at 48 hour after restoration of spontaneous circulation | expressed in ng/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change over troponin-I | at 24 hour and 48 hour after restoration of spontaneous circulation | troponin-I will be expressed in ng/ml |
| change over creatinin kinase-MB | at 24 hour and 48 hour after restoration of spontaneous circulation | CK-MB will be expressed in ng/ml |
| neurologic outcome | an average of 3 weeks after restoration of spontaneous circulation | cerebral performance category scale 1, 2, 3, 4, 5 |
Other
| Measure | Time frame | Description |
|---|---|---|
| neurologic outcome | six month after cardiac arrest | cerebral performance category scale 1, 2, 3, 4, 5 |
| microRNA | at 48 hour after restoration of spontaneous circulation | only in patients with shockable rhythm |
Countries
South Korea
Outcome results
None listed