Out-of-hospital cardiac arrest Circulatory System
Conditions
Interventions
The randomisation is done using an online randomisation tool.
The intervention is one intravenous bolus injection of levosimendan or placebo during ongoing prehospital CPR.
1. A prefilled, blinded,
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years 2. Witnessed OHCA 3. Prompt start of CPR (i.e. within 2 minutes) 4. First recorded rhythm ventricular fibrillation (VF) or pulseless ventricular tachycardia (pVT), or pulseless electrical activity (PEA) in case of suspected pulmonary embolism (as determined by the attending physician) 5. Refractory cardiac arrest, i.e. sustained beyond third rhythm check 6. Intravenous access
Exclusion criteria
Exclusion criteria: 1. Traumatic cause of cardiac arrest 2. First recorded rhythm asystole 3. Time to administration of study drug >30 min after onset of cardiac arrest 4. Known or apparent pregnancy 5. Known pre-existing advanced malignancy, severe neurological or systemic disease, advanced cardiac or pulmonary disease, terminal chronic kidney disease on dialysis or ongoing bleeding 6. Known pre-existing (i.e. current) Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival at day 30 (binary) measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records: 1. Conversion to potentially perfusing rhythm (except VT) among patients without potentially perfusing rhythm at study start (binary) 2. Any ROSC (i.e. return of spontaneous pulse or blood pressure as determined by the treating clinician) (binary) 3. Transport to hospital (binary) 4. Survived event (i.e. ROSC sustained until arrival at the emergency department and transfer of care to medical staff at the receiving hospital) (binary) 5. Sustained ROSC (i.e. =20 min of uninterrupted spontaneous pulse or blood pressure as determined by the treating clinician) (binary) 6. Time to sustained ROSC (continuous, numerical) 7. Hospital arrival status (i.e. subject’s condition at hospital arrival; ROSC, CPR in progress, deceased) (categorical) 8. Number and duration of vasopressor infusions (duration >1 h) in the ICU up to 72 hours (e.g. norepinephrine, epinephrine, phenylephrine, vasopressin, dopamine, methylene blue) (continuous) 9. Number and duration of inotrope infusions (duration >1 h) in the ICU up to 72 hours (e.g. epinephrine, dobutamine, milrinone, levosimendan) (continuous) 10. Mechanical circulatory support in the ICU within 7 days (e.g. veno-arterial extracorporeal membrane oxygenation [VA-ECMO], Impella device, intra-aortic balloon pump) (binary) 11. Organ dysfunction (e.g. renal, hepatic, cardiac) (exploratory) 12. Neurological outcome at discharge (i.e. cerebral performance category 1–2 or 3–5) (binary) 13. Circumstances of death (categorical) 14. Plasma concentration of levosimendan (during initial 72 hours in the intensive care unit) (continuous) 15. Organ donation (i.e. =1 solid organ donated for transplantation) (binary) | — |
Countries
Sweden
Contacts
Public ContactMalin Jonsson Fagerlund
Outcome results
None listed