ESKETAMINE HYDROCHLORIDE for Out-of-hospital cardiac arrest

Inclusion criteria

• {"criterion_text":"- 1.\tAge ≥18 years (presumed if not known)\n- 2.\tOHCA of presumed cardiac cause. *\n- 3.\tPrimary shockable rhythm (ventricular fibrillation or pulseless ventricular tachycardia) **\n- 4.\tDecision to perform prehospital intubation after resuscitation (as decided by treating physician) or intubated during CPR with additional need for sedation.\n- 5.\tAdministration of study medicine injection before hospital arrival is considered feasible.\n- 6.\tROSC with MAP ≥40 mmHg *i.e. admission to Rigshospitalet or Odense University Hospital: national guidelines state that all OHCA patients with presumed cardiac arrest must be referred to the two main hospitals in the respective regions — Rigshospitalet for all OHCA cases in Region Zealand and the Capital Region, and Odense University Hospital for all OHCA cases in Region South. **If a defibrillator shock by an automated external defibrillator is delivered or advised before arrival of the EMS, it is considered a “primary shockable rhythm.”"}

Exclusion criteria

• {"criterion_text":"- 1.\tAdvanced life support TOR exclusion criteria fulfilled\n- 2.\tRefractory cardiac arrest transferred for extracorporeal membrane oxygenation\n- 3.\tWoman of childbearing capacity (female aged 18-40, decided by the treating physician if no information is available)\n- 4.\tKnown therapy limitation (known decision made of no resuscitation or intensive therapy)\n- 5.\tKnown allergy to ketamine or propofol\n- 6.\tSystolic blood pressure >190 mmHg\n- 7.\tKnown chronic disease making 180-day survival unlikely\n- 8.\tKnown pre-arrest mRS score of ≤5\n- 9.\tNursing home resident\n- 10.\tTemperature upon admission <30° C"}

Primary endpoints

• {"endpoint_text":"- Neuron-specific enolase (NSE) measured 48 hours after OHCA","definition_or_measurement_approach":"NSE biomarker measured 48 hours after out-of-hospital cardiac arrest (measurement timepoint specified as 48 hours)."}

Secondary endpoints

• {"endpoint_text":"- Death from all causes at 180 days after cardiac arrest.\n- CPC- and mRS score at hospital discharge and 180-240 days after cardiac arrest.","definition_or_measurement_approach":"Death from all causes assessed at 180 days post-arrest. Cerebral Performance Category (CPC) and modified Rankin Scale (mRS) scores assessed at hospital discharge and at 180-240 days after cardiac arrest."}

Denmark

Earliest CTIS Part Ii Submission Date

27-09-2024

Latest Decision Or Authorization Date

01-10-2024

Processing Time Days

4

Number Of Sites

2

Number Of Participants

282

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"[{\"id\":593667,\"code\":\"1\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}