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

Not Applicable

Terminated

• Conditions: Out-Of-Hospital Cardiac Arrest
• Interventions: Procedure: Remote ischemic post-conditioning

• Registration Number: NCT03093948
• Lead Sponsor: Chonnam National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-17
• Study Start: 2017-03-21
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-28
• Primary Completion: 2019-10-21
• Study Completion: 2019-10-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Ischemic post-conditioning	Remote ischemic post-conditioning	-

Primary Outcome Measures

Name	Time	Method
neuron specific enolase	at 48 hour after restoration of spontaneous circulation	expressed in ng/ml

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of