Cardiopulmonary Arrest(iCPR)NCT05253937
Impact of Intracoronary Versus Intravenous Epinephrine Administration During Cardiac Arrest .
An observational study of Cardiopulmonary Arrest and Epinephrine Causing Adverse Effects in Therapeutic Use, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Arrest, Epinephrine Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Epinephrin
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Apr 2018to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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.
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 .
Read more
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.
- Being tested
- Epinephrin
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intracoronary Epinephrine administration during cardiac arrest | Not described Receives: Drug: Epinephrin | |
| Peripheral intravenous Epinephrine administration during cardiac arrest | Not described Receives: Drug: Epinephrin | |
| Central intravenous Epinephrine administration during cardiac arrest | Not described Receives: Drug: Epinephrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 24 hours
Secondary outcomes (1)
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 .
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Apr 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor Scott and White Health, Minneapolis Heart Institute
- Responsible party
- Principal investigator, Ali Aldujeli, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253937
- Sponsor's protocol ID
- LUHSKC-175
- Acronym
- (iCPR)
- Status last verified
- Aug 2022
- First submitted
- 23 Jan 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36539907
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05253937
- Acronym / sponsor ID
- (iCPR) / LUHSKC-175
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Baylor Scott and White Health, Minneapolis Heart Institute
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpinephrinThe 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. | Drug | Central intravenous Epinephrine administration during cardiac arrest, Intracoronary Epinephrine administration during cardiac arrest, Peripheral intravenous Epinephrine administration during cardiac arrest |
Primary outcome
ROSC (return of spontaneous circulation) between different routes of epinephrine administration.
Time frame: Up to 24 hours
Return of sinus rhythm or atrial fibrillation/flutter for more than 5 minutes (through ECG monitoring)
1 secondary outcome
Survival to hospital discharge with favorable neurologic status (CPC score1-2)
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Derived from this study: PubMed 36539907Aldujeli 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.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiopulmonary Arrest
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Arrest and Epinephrine Causing Adverse Effects in Therapeutic Use, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROSC (return of spontaneous circulation) between different routes of epinephrine administration. (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05253937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.