Impact of Intracoronary Versus Intravenous Epinephrine Administration During Cardiac Arrest .

Cardiopulmonary Arrest Clinical Trial

— (iCPR)  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05253937
• Other study ID #: LUHSKC-175
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2022
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Cardiopulmonary Arrest
• Epinephrine Causing Adverse Effects in Therapeutic Use
• Heart Arrest

Intervention

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.

Locations

Country	Name	City	State
Lithuania	Ali Aldujeli	Kaunas

Sponsors (3)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	Baylor Scott and White Health, Minneapolis Heart Institute

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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