(iCPR): Impact of Intracoronary Versus Intravenous Epinephrine Administration During Cardiac Arrest .

Sponsor
Lithuanian University of Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT05253937
Collaborator
Baylor Scott and White Health (Other), Minneapolis Heart Institute (Other)
160
1
50
3.2

Study Details

Study Description

Brief Summary

In hospital cardiac arrest (IHCA) is a major challenge imposed on almost all health care systems worldwide. Despite significant progress in cardiopulmonary resuscitation in the past few years, outcomes remain relatively poor with an approximate 49 % survival rate.

Epinephrine administration remains a cornerstone in the treatment of cardiac arrest. However, the preferred route of administration remains a matter of debate within the medical community .

Various routes of administration, including intravenous, intramuscular, intraosseous and endotracheal routes have been studied.

Initially, American guidelines for the treatment of cardiac arrest recommended injection of 0.5 mg of epinephrine directly into the right ventricle through the parasternal approach, aiming to achieve higher peak intracardiac concentrations and a more central effect, however the intravenous route remained preferable due to its feasibility and safety .

To our knowledge, intra-coronary epinephrine administration for intraprocedural cardiac arrest has not been evaluated or compared with other routes of administration.

Study Design

Study Type:
Observational
Actual Enrollment :
160 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Intracoronary Versus Central and Peripheral Intravenous Epinephrine Administration During Cardiac Arrest in The Cardiac Catheterization Laboratory for Acute Myocardial Infarction Patients.
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Intracoronary Epinephrine administration during cardiac arrest

Drug: Epinephrin
The study will enroll acute myocardial infarction patients who suffered from a cardiac arrest in the cardiac catheterization laboratory during percutaneous intervention procedure. Cardiac Resuscitation was performed according to the European Resuscitation Council (ERC) Guidelines. The preferred route of epinephrine administration was through the central venous access (by internal jugular or subclavian vein). Thus, if available, it was the preferred method of medication delivery. However, in cases without central venous access, the route of epinephrine administration (peripheral intravenous or arterial intracoronary) during cardiac arrest was left to the treating physicians.

Peripheral intravenous Epinephrine administration during cardiac arrest

Drug: Epinephrin
The study will enroll acute myocardial infarction patients who suffered from a cardiac arrest in the cardiac catheterization laboratory during percutaneous intervention procedure. Cardiac Resuscitation was performed according to the European Resuscitation Council (ERC) Guidelines. The preferred route of epinephrine administration was through the central venous access (by internal jugular or subclavian vein). Thus, if available, it was the preferred method of medication delivery. However, in cases without central venous access, the route of epinephrine administration (peripheral intravenous or arterial intracoronary) during cardiac arrest was left to the treating physicians.

Central intravenous Epinephrine administration during cardiac arrest

Drug: Epinephrin
The study will enroll acute myocardial infarction patients who suffered from a cardiac arrest in the cardiac catheterization laboratory during percutaneous intervention procedure. Cardiac Resuscitation was performed according to the European Resuscitation Council (ERC) Guidelines. The preferred route of epinephrine administration was through the central venous access (by internal jugular or subclavian vein). Thus, if available, it was the preferred method of medication delivery. However, in cases without central venous access, the route of epinephrine administration (peripheral intravenous or arterial intracoronary) during cardiac arrest was left to the treating physicians.

Outcome Measures

Primary Outcome Measures

  1. ROSC (return of spontaneous circulation) between different routes of epinephrine administration. [Up to 24 hours]

    Return of sinus rhythm or atrial fibrillation/flutter for more than 5 minutes (through ECG monitoring)

Secondary Outcome Measures

  1. Survival to hospital discharge with favorable neurologic status (CPC score1-2) [Up to 30 days]

    Cerebral Performance Category (CPC) - a five point scale that ranges from good cerebral performance (1) to brain death (5), is often used and is commonly dichotomized into "good" (CPC 1-2) versus "poor" (CPC 3-5) outcome .

Other Outcome Measures

  1. inhospital stent thrombosis [Up to 30 days]

    Stent thrombosis confirmed by diagnostic angiography or sudden ST elevation on ECG in the specific segments confounding with stent location

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Aged above 18 years old

  • Diagnosed with non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)

  • Received dual antiplatelet therapy (acetylsalicylic acid and ticagrelor), or triple therapy (oral anticoagulant, acetylsalicylic acid and clopidogrel)

  • Event of cardiac arrest during percutaneous intervention

Exclusion Criteria:
  • cardiac arrest documented prior to being transported to cardiac catheterization laboratory.

  • Patients who suffered cardiac arrest for less than 60 seconds were excluded from the study.

  • Received mechanical circulatory support such as intra-aortic balloon pump, temporary percutaneous ventricular assist devices, or extracorporeal membrane oxygenation (ECMO) during hospitalization.

  • Presenting with any cardiac rhythm on admission other than sinus rhythm or atrial fibrillation/flutter

  • Signs of infection or a history of hepatic, oncologic or allergy to contrast media and end stage renal failure

  • Patients who underwent primary fibrinolysis.

  • Furthermore, patients who received atropine, amiodarone, lidocaine, or any other antiarrhythmic prior to CPR

  • who received targeted temperature management post CPR .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ali Aldujeli Kaunas Lithuania LT-50161

Sponsors and Collaborators

  • Lithuanian University of Health Sciences
  • Baylor Scott and White Health
  • Minneapolis Heart Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ali Aldujeli, Cardiovascular disease consultant, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier:
NCT05253937
Other Study ID Numbers:
  • LUHSKC-175
First Posted:
Feb 24, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022