Use of Isoprenaline with Epinephrine During Out-of-Hospital Cardiac Arrest with Non-Shockable Rhytm (EPISO)

2024-516074-29-01 Therapeutic confirmatory (Phase III) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruitment pending
Participants planned 1,178
Countries 1
Sites 2

Cardiac arrest

To determine whether the combined use of isoprenaline with epinephrine increases the chance of sustained return of spontaneous circulation during out-of-hospital cardiac arrest with non-shockable rhythm compared with epinephrine alone.

Key facts

Sponsor
Odense University Hospital
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Decision date (initial)
2025-08-11
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2024-516074-29-01
ClinicalTrials.gov
NCT06473116

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To determine whether the combined use of isoprenaline with epinephrine increases the chance of sustained return of spontaneous circulation during out-of-hospital cardiac arrest with non-shockable rhythm compared with epinephrine alone.

Secondary objectives 5

  1. To evaluate whether the use of isoprenaline with epinephrine increases the rate of conversions from non-shockable to a shockable heart rhythm in patients with out-of-hospital cardiac arrest compared with epinephrine alone.
  2. To evaluate whether the use of isoprenaline with epinephrine improves the chance of good neurological outcome at discharge in patients with out-of-hospital cardiac arrest compared with epinephrine alone.
  3. To evaluate whether the use of isoprenaline with epinephrine increases the chance of achieving return of spontaneous circulation at hospital arrival in patients with out-of-hospital cardiac arrest compared with epinephrine alone.
  4. To evaluate whether the use of isoprenaline with epinephrine increases 30-day survival in patients with out-of-hospital cardiac arrest compared with epinephrine alone.
  5. To evaluate whether the use of isoprenaline with epinephrine improves the chance of good neurological outcome at 90 days in patients with out-of-hospital cardiac arrest compared with epinephrine alone.

Conditions and MedDRA coding

Cardiac arrest

VersionLevelCodeTermSystem organ class
20.0 PT 10007515 Cardiac arrest 100000004849

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Men and women with bystander and/or emergency medical service personnel witnessed out-of-hospital cardiac arrest.
  2. Age ≥18 years.
  3. Initial rhythm non-shockable rhythm (PEA or asystole).
  4. Advanced life support initiated or continued by EMS personnel.

Exclusion criteria 6

  1. Cardiac arrest caused by or suspected to be caused by blunt trauma, penetrating trauma, or burn injury.
  2. Cardiac arrest caused by or suspected to be caused by drowning, hanging, strangulation, and foreign body airway obstruction.
  3. IV epinephrine already administered prior to EMS arrival.
  4. Prior enrollment in the trial.
  5. Patient with cardiac arrest at nursing homes.
  6. Known or apparent pregnancy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Sustained return of spontaneous circulation of at least 20 minutes.

Secondary endpoints 5

  1. Conversion from non-shockable to shockable rhythm
  2. Favorable neurological outcome at hospital discharge
  3. ROSC at hospital arrival
  4. Thirty-day survival
  5. Favorable neurological outcome at 90 days.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Isoprenaline Hydrochloride

SCP228918 · ATC

Active substance
Isoprenaline Hydrochloride
Substance synonyms
ISOPROTERENOL HYDROCHLORIDE
Route of administration
INTRAVENOUS BOLUS USE
Max daily dose
1600 µg microgram(s)
Max total dose
1600 µg microgram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
C01CA02 — ISOPRENALINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Potassium Chloride Ph. Eur.

SCP12712712 · ATC

Active substance
Potassium Chloride Ph. Eur.
Route of administration
INTRAVENOUS BOLUS USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
B05XA03 — SODIUM CHLORIDE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Produced by the Pharmacy in the Capital Region in Denmark - there is no EU MP number or EU substance number for this product, but I cannot choose unauthorized product otherwise.

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Odense University Hospital

51 Total trials 30 Recruiting 11 Ended
Academic / Non-commercial
Sponsor organisation
Odense University Hospital
Address
J B Winsloews Vej 4
City
Odense C
Postcode
5000
Country
Denmark

Scientific contact point

Organisation
Odense University Hospital
Contact name
Research Department of Cardiology

Public contact point

Organisation
Odense University Hospital
Contact name
Research Department of Cardiology

Third parties 2

OrganisationCity, countryDuties
Region Hovedstadens Apotek Herlev Hospital
ORG-100024582
 Herlev, Denmark Code 14
Odense University Hospital
ORG-100007716
 Odense C, Denmark On site monitoring, E-data capture, Code 8

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Authorised, recruitment pending 1,178 2
Rest of world — 0 —

Investigational sites

Denmark

2 sites · Authorised, recruitment pending
Rigshospitalet
Hjertecentret, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Kardiologisk Forskningsenhed, J B Winsloews Vej 4, 5000, Odense C

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_ Protocol 2024-516074-29 pdf 4
Protocol (for publication) D1_ Protocol 2024-516074-29 with changes 4
Recruitment arrangements (for publication) K1_Recruitment arrangements EPISO 2
Subject information and informed consent form (for publication) L1_ SIS and ICF Closest relative Biobank OUH 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Closest relative Biobank RH 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Closest relative Consent form OUH 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Closest relative Consent form RH 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Independent doctor and Legally designated representative Consent Form 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Patient Biobank OUH with changes 2
Subject information and informed consent form (for publication) L1_ SIS and ICF Patient Biobank RH with changes 2
Subject information and informed consent form (for publication) L1_ SIS and ICF Patient Consent form OUH 2
Subject information and informed consent form (for publication) L1_ SIS and ICF Patient Consent form RH with changes 2
Subject information and informed consent form (for publication) L1_SIS and ICF Closest relative to deceased OUH-RH 1
Summary of Product Characteristics (SmPC) (for publication) E2_ SmPC Isoprenaline Hydrochloride 1
Synopsis of the protocol (for publication) D1_ Protocol synopsis_ENG 2024-516074-29 2

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-05-13 Denmark Acceptable
2025-07-31
 2025-08-11

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