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

Impact of Intracoronary Versus Central and Peripheral Intravenous Epinephrine Administration During Cardiac Arrest in The Cardiac Catheterization Laboratory for Acute Myocardial Infarction Patients.

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 Overview

• Status: Completed
• Conditions: Cardiopulmonary Arrest; Epinephrine Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Drug: Epinephrin

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania, LT-50161
    • Ali Aldujeli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This is a prospective, cohort, dual center pilot study, conducted in the Hospital of the Lithuanian University of Health Sciences Kaunas Clinics and the Republican Hospital of Panevezys from 2018 to 2022. Both cardiac centers covers six out of ten administrative regions in the republic of Lithuania.

Description

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 .

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROSC (return of spontaneous circulation) between different routes of epinephrine administration.	Return of sinus rhythm or atrial fibrillation/flutter for more than 5 minutes (through ECG monitoring)	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival to hospital discharge with favorable neurologic status (CPC score1-2)	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 .	Up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
inhospital stent thrombosis	Stent thrombosis confirmed by diagnostic angiography or sudden ST elevation on ECG in the specific segments confounding with stent location	Up to 30 days

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Collaborators: Baylor Scott and White Health; Minneapolis Heart Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): June 1, 2022

Study Registration Dates

• First Submitted: January 23, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (ACTUAL): February 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine
• Other Study ID Numbers: LUHSKC-175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No