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

Chonnam National University

Status

Terminated

Conditions

Out-Of-Hospital Cardiac Arrest

Treatments

Procedure: Remote ischemic post-conditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT03093948

CNUH-2017-051

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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