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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Remote Ischemic Post-conditioning on Neurologic and Cardiac Recovery in Out-of-hospital Cardiac Arrest

Conditions
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Out-Of-Hospital Cardiac Arrest

Intervention / Treatment
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* Procedure: Remote ischemic post-conditioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Ischemic post-conditioning<br> | Procedure: Remote ischemic post-conditioning<br>* 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.<br>|
| No Intervention: standard of care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuron specific enolase | expressed in ng/ml | at 48 hour after restoration of spontaneous circulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change over troponin-I | troponin-I will be expressed in ng/ml | at 24 hour and 48 hour after restoration of spontaneous circulation | 
| change over creatinin kinase-MB | CK-MB will be expressed in ng/ml | at 24 hour and 48 hour after restoration of spontaneous circulation | 
| neurologic outcome | cerebral performance category scale 1, 2, 3, 4, 5 | an average of 3 weeks after restoration of spontaneous circulation |