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

Primary Purpose

Out-Of-Hospital Cardiac Arrest

Status

Terminated

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Remote ischemic post-conditioning

About this trial

This is an interventional treatment trial for Out-Of-Hospital Cardiac Arrest

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chonnam National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Remote Ischemic post-conditioning

standard of care

Arm Description

Outcomes

Primary Outcome Measures

neuron specific enolase

expressed in ng/ml

Secondary Outcome Measures

change over troponin-I

troponin-I will be expressed in ng/ml

change over creatinin kinase-MB

CK-MB will be expressed in ng/ml

neurologic outcome

cerebral performance category scale 1, 2, 3, 4, 5

Full Information

NCT ID

NCT03093948

First Posted

March 17, 2017

Last Updated

January 25, 2021

Sponsor

Chonnam National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03093948

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Terminated

Why Stopped

Overlap with other RCT

Study Start Date

March 21, 2017 (Actual)

Primary Completion Date

October 21, 2019 (Actual)

Study Completion Date

October 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chonnam National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Out-Of-Hospital Cardiac Arrest

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Remote Ischemic post-conditioning

Arm Type

Experimental

Arm Title

standard of care

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

Remote ischemic post-conditioning

Intervention Description

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.

Primary Outcome Measure Information:

Title

neuron specific enolase

Description

expressed in ng/ml

Time Frame

at 48 hour after restoration of spontaneous circulation

Secondary Outcome Measure Information:

Title

change over troponin-I

Description

troponin-I will be expressed in ng/ml

Time Frame

at 24 hour and 48 hour after restoration of spontaneous circulation

Title

change over creatinin kinase-MB

Description

CK-MB will be expressed in ng/ml

Time Frame

at 24 hour and 48 hour after restoration of spontaneous circulation

Title

neurologic outcome

Description

cerebral performance category scale 1, 2, 3, 4, 5

Time Frame

an average of 3 weeks after restoration of spontaneous circulation

Other Pre-specified Outcome Measures:

Title

microRNA

Description

only in patients with shockable rhythm

Time Frame

at 48 hour after restoration of spontaneous circulation

Title

neurologic outcome

Description

cerebral performance category scale 1, 2, 3, 4, 5

Time Frame

six month after cardiac arrest

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Byungkook Lee, M.D.

Organizational Affiliation

Department of Emergency Medicine, Chonnam National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chonnam National University Hospital

City

Gwangju

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

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21796098

Citation

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

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