N/A for Cardiac arrest

Inclusion criteria

• {"criterion_text":"- Witnessed OHCA\n- Prompt start of CPR (within 2 minutes)\n- First recorded rhythm VF or pVT, or PEA in case of suspected pulmonary embolism (as determined by the attending physician)\n- Refractory cardiac arrest, i.e. sustained beyond third rhythm check\n- Intravenous access\n- Age 18-75 years"}

Exclusion criteria

• {"criterion_text":"- Traumatic cause of cardiac arrest\n- First recorded rhythm asystole\n- Time to administration of study drug >30 min after onset of cardiac arrest\n- Known or apparent pregnancy\n- Known pre-existing severe neurological or systemic disease (e.g. severe dementia, current advanced malignancy, advanced cardiac or pulmonary disease, terminal chronic kidney disease on dialysis)\n- Known pre-existing (i.e. current) DNACPR decision"}

Primary endpoints

• {"endpoint_text":"- Survival at day 30 (binary)","definition_or_measurement_approach":"Survival at day 30 (binary)"}

Secondary endpoints

• {"endpoint_text":"- Conversion to potentially perfusing rhythm (except VT) among patients without potentially perfusing rhythm at study start (binary).","definition_or_measurement_approach":"Binary"}
• {"endpoint_text":"- Any ROSC (i.e. return of spontaneous pulse or blood pressure as determined by the treating clinician) (binary).","definition_or_measurement_approach":"Binary; return of spontaneous pulse or blood pressure as determined by the treating clinician"}
• {"endpoint_text":"- Transport to hospital (binary).","definition_or_measurement_approach":"Binary"}
• {"endpoint_text":"- Survived event (i.e. ROSC sustained until arrival at the emergency department and transfer of care to medical staff at the receiving hospital) (binary)","definition_or_measurement_approach":"Binary; ROSC sustained until arrival at ED and transfer of care"}
• {"endpoint_text":"- Sustained ROSC (i.e. ≥20 min of uninterrupted spontaneous pulse or blood pressure as determined by the treating clinician) (binary)","definition_or_measurement_approach":"Binary; ≥20 minutes of uninterrupted spontaneous pulse or blood pressure"}
• {"endpoint_text":"- Time to sustained ROSC (continuous, numerical)","definition_or_measurement_approach":"Continuous numerical measure of time to sustained ROSC"}
• {"endpoint_text":"- Hospital arrival status (i.e. subject’s condition at hospital arrival; ROSC, CPR in progress, deceased) (categorical)","definition_or_measurement_approach":"Categorical: condition at hospital arrival (ROSC, CPR in progress, deceased)"}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Count and duration (with duration >1 h) of vasopressor infusions in ICU up to 72 hours"}
• {"endpoint_text":"- Number and duration of inotrope infusions (duration >1 h) in the ICU up to 72 hours (e.g. epinephrine, dobutamine, milrinone, levosimendan)","definition_or_measurement_approach":"Count and duration (with duration >1 h) of inotrope infusions in ICU up to 72 hours"}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Binary; occurrence of mechanical circulatory support in ICU within 7 days"}
• {"endpoint_text":"- Organ dysfunction (e.g. renal, hepatic, cardiac) (exploratory)","definition_or_measurement_approach":"Exploratory; organ dysfunction (examples: renal, hepatic, cardiac)"}
• {"endpoint_text":"- Neurological outcome at discharge (i.e. cerebral performance category) (1–2 or 3–5) (binary)","definition_or_measurement_approach":"Binary; cerebral performance category at discharge (1–2 vs 3–5)"}
• {"endpoint_text":"- Circumstances of death (categorical)","definition_or_measurement_approach":"Categorical"}
• {"endpoint_text":"- Plasma concentration of levosimendan (intervention group); undetectable plasma concentration of levosimendan (control group) (during initial 72 hours in the intensive care unit) (binary)","definition_or_measurement_approach":"Binary; detectable plasma levosimendan in intervention vs undetectable in control during initial 72 hours in ICU"}
• {"endpoint_text":"- Organ donation (i.e. ≥1 solid organ donated for transplantation) (binary)","definition_or_measurement_approach":"Binary; ≥1 solid organ donated for transplantation"}

Other endpoints

• {"endpoint_text":"- Organ dysfunction (e.g. renal, hepatic, cardiac) (exploratory)","definition_or_measurement_approach":"Exploratory; organ dysfunction (e.g. renal, hepatic, cardiac)"}

Sweden

Earliest CTIS Part Ii Submission Date

14-05-2025

Latest Decision Or Authorization Date

11-06-2025

Processing Time Days

28

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Karolinska University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"","full_name":"Region Stockholm","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Swedish Medical Society","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Swedish Heart and lung foundation","duties_or_roles":"Monetary support","organisation_type":""}