Clinical trial NCT03093948: Effect of Remote Ischemic Post-conditioning on Out-of-hospital Cardiac Arrest
Official title: Effect of Remote Ischemic Post-conditioning on Neurologic and Cardiac Recovery in Out-of-hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: neuron specific enolase
timeFrame: at 48 hour after restoration of spontaneous circulation
Secondary outcomes:
measure: change over troponin-I
timeFrame: at 24 hour and 48 hour after restoration of spontaneous circulation
measure: change over creatinin kinase-MB
timeFrame: at 24 hour and 48 hour after restoration of spontaneous circulation
measure: neurologic outcome
timeFrame: an average of 3 weeks after restoration of spontaneous circulation
Other outcomes:
measure: microRNA
timeFrame: at 48 hour after restoration of spontaneous circulation
measure: neurologic outcome
timeFrame: six month after cardiac arrest
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
affiliation: Department of Emergency Medicine, Chonnam National University Hospital
name: Byungkook Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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