NCT05253937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

January 23, 2022

Last Update Submit

August 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Survival to hospital discharge with favorable neurologic status (CPC score1-2)

    Up to 30 days

Other Outcomes (1)

  • inhospital stent thrombosis

    Up to 30 days

Study Arms (3)

Intracoronary Epinephrine administration during cardiac arrest

Drug: Epinephrin

Peripheral intravenous Epinephrine administration during cardiac arrest

Drug: Epinephrin

Central intravenous Epinephrine administration during cardiac arrest

Drug: Epinephrin

Interventions

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 arrestIntracoronary Epinephrine administration during cardiac arrestPeripheral intravenous Epinephrine administration during cardiac arrest

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali Aldujeli

Kaunas, LT-50161, Lithuania

Location

Related Publications (1)

  • Aldujeli A, Haq A, Tecson KM, Kurnickaite Z, Lickunas K, Bailey S, Tatarunas V, Braukyliene R, Baksyte G, Aldujeili M, Khalifeh H, Briedis K, Ordiene R, Unikas R, Hamadeh A, Brilakis ES. A prospective observational study on impact of epinephrine administration route on acute myocardial infarction patients with cardiac arrest in the catheterization laboratory (iCPR study). Crit Care. 2022 Dec 20;26(1):393. doi: 10.1186/s13054-022-04275-8.

MeSH Terms

Conditions

Heart Arrest

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiovascular disease consultant

Study Record Dates

First Submitted

January 23, 2022

First Posted

February 24, 2022

Study Start

April 1, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2022

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations