Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515987-29-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
OHCA is a critical medical emergency with significant mortality and morbidity primarily due to hypoxic-ischemic brain injury (HIBI). Despite advances in resuscitation techniques, the neurological outcomes for survivors remain poor. Current post-resuscitation practices lack specific neuroprotective strategies. Ketamine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, has shown potential neuroprotective properties in preclinical and clinical studies due to its ability to inhibit excitotoxicity and reduce neuronal apoptosis. This trial hypothesizes that ketamine, when used for sedation in OHCA patients, may offer superior neuroprotective benefits compared to the commonly used sedative propofol. By comparing the effects of ketamine and propofol on neuronal damage markers and long-term neurological outcomes, this study aims to identify a potentially effective intervention to improve the prognosis of OHCA patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-ketamin | Experimental | Intravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine |
|
| Propofol | Active Comparator | Prehospital intravenous or intraosseous bolus administration of a minimum dose of 0.25 mg/kg propofol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esketamine hydrochloride | Drug | Prehospital intravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuron-specific enolase (NSE) measured 48 hours after OHCA | To determine the neuroprotective efficacy of ketamine compared with propofol administered as part of sedation for intubation after initial resuscitation from OHCA | 48 hours after OHCA |
| Measure | Description | Time Frame |
|---|---|---|
| Death from any cause | Death from any cause 180 days after cardiac arrest | 180 days after cardiac arrest |
| Neurological outcome: modified Rankin Score (mRS) | Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salma Charabi, MD | Contact | 35450572 | salma.charabi@regionh.dk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| propofol | Drug | Prehospital intravenous or intraosseous bolus administration at a minimum dose of 0.25 mg/kg propofol |
|
| At 2 weeks (at discharge) |
| Neurological outcome: Cerebral Performance Categories (CPC) | Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function). | At 2 weeks (at discharge) |
| Neurological outcome: modified Rankin Score (mRS) | Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms. | At 180 days after OHCA. |
| Neurological outcome: modified Rankin Score (mRS) | Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms. | At 240 days after OHCA. |
| Neurological outcome: Cerebral Performance Categories (CPC) | Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function). | At 180 days after OHCA. |
| Neurological outcome: Cerebral Performance Categories (CPC) | Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function). | At 240 days after OHCA. |
| Odense University Hospital | Not yet recruiting | Odense C | 5000 | Denmark |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |