Effect of Remote Ischemic Post-conditioning on Out-of-hospital Cardiac Arrest
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|ClinicalTrials.gov Identifier: NCT03093948|
Recruitment Status : Terminated (Overlap with other RCT)
First Posted : March 28, 2017
Last Update Posted : January 27, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Out-Of-Hospital Cardiac Arrest||Procedure: Remote ischemic post-conditioning||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Remote Ischemic Post-conditioning on Neurologic and Cardiac Recovery in Out-of-hospital Cardiac Arrest|
|Actual Study Start Date :||March 21, 2017|
|Actual Primary Completion Date :||October 21, 2019|
|Actual Study Completion Date :||October 21, 2019|
|Experimental: Remote Ischemic post-conditioning||
Procedure: Remote 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.
|No Intervention: standard of care|
- neuron specific enolase [ Time Frame: at 48 hour after restoration of spontaneous circulation ]expressed in ng/ml
- change over troponin-I [ Time Frame: at 24 hour and 48 hour after restoration of spontaneous circulation ]troponin-I will be expressed in ng/ml
- change over creatinin kinase-MB [ Time Frame: at 24 hour and 48 hour after restoration of spontaneous circulation ]CK-MB will be expressed in ng/ml
- neurologic outcome [ Time Frame: an average of 3 weeks after restoration of spontaneous circulation ]cerebral performance category scale 1, 2, 3, 4, 5
- microRNA [ Time Frame: at 48 hour after restoration of spontaneous circulation ]only in patients with shockable rhythm
- neurologic outcome [ Time Frame: six month after cardiac arrest ]cerebral performance category scale 1, 2, 3, 4, 5
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093948
|Korea, Republic of|
|Chonnam National University Hospital|
|Gwangju, Korea, Republic of|
|Principal Investigator:||Byungkook Lee, M.D.||Department of Emergency Medicine, Chonnam National University Hospital|