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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
Sponsor:
Information provided by (Responsible Party):
ByungKook Lee, Chonnam National University Hospital

Tracking Information
First Submitted Date  ICMJE March 17, 2017
First Posted Date  ICMJE March 28, 2017
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE March 21, 2017
Actual Primary Completion Date October 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
neuron specific enolase [ Time Frame: at 48 hour after restoration of spontaneous circulation ]
expressed in ng/ml
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 22, 2017)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Remote Ischemic Post-conditioning on Out-of-hospital Cardiac Arrest
Official Title  ICMJE Effect of Remote Ischemic Post-conditioning on Neurologic and Cardiac Recovery in Out-of-hospital Cardiac Arrest
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Out-Of-Hospital Cardiac Arrest
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Remote Ischemic post-conditioning
    Intervention: Procedure: Remote ischemic post-conditioning
  • No Intervention: standard of care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 25, 2021)
58
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2017)
118
Actual Study Completion Date  ICMJE October 21, 2019
Actual Primary Completion Date October 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03093948
Other Study ID Numbers  ICMJE CNUH-2017-051
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ByungKook Lee, Chonnam National University Hospital
Study Sponsor  ICMJE Chonnam National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Byungkook Lee, M.D. Department of Emergency Medicine, Chonnam National University Hospital
PRS Account Chonnam National University Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP