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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

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.


Condition or disease Intervention/treatment Phase
Out-Of-Hospital Cardiac Arrest Procedure: Remote ischemic post-conditioning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. neuron specific enolase [ Time Frame: at 48 hour after restoration of spontaneous circulation ]
    expressed in ng/ml


Secondary Outcome Measures :
  1. 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

  2. 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

  3. neurologic outcome [ Time Frame: an average of 3 weeks after restoration of spontaneous circulation ]
    cerebral performance category scale 1, 2, 3, 4, 5


Other Outcome Measures:
  1. microRNA [ Time Frame: at 48 hour after restoration of spontaneous circulation ]
    only in patients with shockable rhythm

  2. neurologic outcome [ Time Frame: six month after cardiac arrest ]
    cerebral performance category scale 1, 2, 3, 4, 5



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Sponsors and Collaborators
Chonnam National University Hospital
Investigators
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Principal Investigator: Byungkook Lee, M.D. Department of Emergency Medicine, Chonnam National University Hospital
Publications of Results:
Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15. Erratum in: Circulation. 2011 Feb 15;123(6):e240. Circulation. 2011 Oct 18;124(16):e426.

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Responsible Party: ByungKook Lee, Associate professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT03093948    
Other Study ID Numbers: CNUH-2017-051
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases