Clinical trial • Phase IV • Cardiology
ISOPRENALINE HYDROCHLORIDE for Cardiac arrest
Phase IV trial of ISOPRENALINE HYDROCHLORIDE for Cardiac arrest.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Cardiac arrest
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 13-05-2025
- First CTIS Authorization Date
- 11-08-2025
Trial design
Epinephrine alone (standard care); dose and schedule not specified in provided record.-controlled Phase IV trial across 2 sites in Denmark.
- Comparator
- Epinephrine alone (standard care); dose and schedule not specified in provided record.
- Target Sample Size
- 1178
- Trial Duration For Participant
- 90
Eligibility
Recruits 1178 isVulnerablePopulationSelected = true. Consent/assent handled using subject information and informed consent forms for patients and multiple surrogate consent pathways: closest relative consent forms, independent doctor and legally designated representative consent form, 'closest relative to deceased' form, and biobank consent forms (as indicated by available L1 SIS and ICF documents)..
- Pregnancy Exclusion
- Known or apparent pregnancy.
- Vulnerable Population
- isVulnerablePopulationSelected = true. Consent/assent handled using subject information and informed consent forms for patients and multiple surrogate consent pathways: closest relative consent forms, independent doctor and legally designated representative consent form, 'closest relative to deceased' form, and biobank consent forms (as indicated by available L1 SIS and ICF documents).
Inclusion criteria
- {"criterion_text":"- Men and women with bystander and/or emergency medical service personnel witnessed out-of-hospital cardiac arrest.\n- Age ≥18 years.\n- Initial rhythm non-shockable rhythm (PEA or asystole).\n- Advanced life support initiated or continued by EMS personnel."}
Exclusion criteria
- {"criterion_text":"- Cardiac arrest caused by or suspected to be caused by blunt trauma, penetrating trauma, or burn injury.\n- Cardiac arrest caused by or suspected to be caused by drowning, hanging, strangulation, and foreign body airway obstruction.\n- IV epinephrine already administered prior to EMS arrival.\n- Prior enrollment in the trial.\n- Patient with cardiac arrest at nursing homes.\n- Known or apparent pregnancy."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Sustained return of spontaneous circulation of at least 20 minutes.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Conversion from non-shockable to shockable rhythm\n- Favorable neurological outcome at hospital discharge\n- ROSC at hospital arrival\n- Thirty-day survival\n- Favorable neurological outcome at 90 days.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 1178
- Recruitment Window Months
- 38
- Consent Approach
- For incapacitated patients and emergency settings, consent pathways include closest relative consent forms, independent doctor and legally designated representative consent form, closest relative to deceased forms, and patient consent forms / biobank consent forms where applicable. Language(s) of documents not specified in the provided record. Age-specific documents not indicated beyond adult inclusion (Age ≥18 years).
Methods
- Recruitment occurs via emergency medical services (EMS) encountering out-of-hospital cardiac arrest patients (advanced life support initiated or continued by EMS); inclusion requires bystander and/or EMS witnessed out-of-hospital cardiac arrest. Country context: Denmark (trial sites and Part II authorization in Denmark).
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 1178
Denmark
- Earliest CTIS Part Ii Submission Date
- 24-07-2025
- Latest Decision Or Authorization Date
- 11-08-2025
- Processing Time Days
- 18
- Number Of Sites
- 2
- Number Of Participants
- 1178
Sites
- Site Name
- Rigshospitalet
- Department Name
- Hjertecentret
- Principal Investigator Name
- Christian Hassager
- Principal Investigator Email
- christian.hassager@regionh.dk
- Contact Person Name
- Christian Hassager
- Contact Person Email
- christian.hassager@regionh.dk
- Site Name
- Odense University Hospital
- Department Name
- Kardiologisk Forskningsenhed
- Principal Investigator Name
- Laura Sarkisian
- Principal Investigator Email
- Laura.Sarkisian2@rsyd.dk
- Contact Person Name
- Laura Sarkisian
- Contact Person Email
- Laura.Sarkisian2@rsyd.dk
Sponsor
Primary sponsor
- Full Name
- Odense University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Region Hovedstadens Apotek Herlev Hospital","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties codes: 1, 7, 8","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- ISOPRENALINE
- Active Substance
- ISOPRENALINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS BOLUS USE
- Route
- INTRAVENOUS BOLUS USE
- Authorisation Status
- prodAuthStatus: 2; marketingAuthNumber: -
- Maximum Dose
- 1600 µg (maxTotalDoseAmount / maxDailyDoseAmount from record)
- Investigational Product Name
- SODIUM CHLORIDE
- Active Substance
- POTASSIUM CHLORIDE PH. EUR., SODIUM CHLORIDE PH. EUR.
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS BOLUS USE
- Route
- INTRAVENOUS BOLUS USE
- Authorisation Status
- prodAuthStatus: 2; marketingAuthNumber: -; product produced by Pharmacy in the Capital Region in Denmark (productChangeDescription present)
- Maximum Dose
- 0 mg
- Combination Treatment
- Yes
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