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

January 25, 2021 updated by: ByungKook Lee, Chonnam National University Hospital

Effect of Remote Ischemic Post-conditioning on Neurologic and Cardiac Recovery in Out-of-hospital Cardiac Arrest

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: standard of care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neuron specific enolase
Time Frame: at 48 hour after restoration of spontaneous circulation
expressed in ng/ml
at 48 hour after restoration of spontaneous circulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 24 hour and 48 hour after restoration of spontaneous circulation
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
at 24 hour and 48 hour after restoration of spontaneous circulation
neurologic outcome
Time Frame: an average of 3 weeks after restoration of spontaneous circulation
cerebral performance category scale 1, 2, 3, 4, 5
an average of 3 weeks after restoration of spontaneous circulation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
microRNA
Time Frame: at 48 hour after restoration of spontaneous circulation
only in patients with shockable rhythm
at 48 hour after restoration of spontaneous circulation
neurologic outcome
Time Frame: six month after cardiac arrest
cerebral performance category scale 1, 2, 3, 4, 5
six month after cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonnam National University Hospital

Investigators

  • Principal Investigator: Byungkook Lee, M.D., Department of Emergency Medicine, Chonnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 21, 2017

Primary Completion (ACTUAL)

October 21, 2019

Study Completion (ACTUAL)

October 21, 2019

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (ACTUAL)

March 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNUH-2017-051

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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