Ketamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest (KETOHCA)

Christian Hassager

Status and phase: Enrolling; Phase 2

Conditions: Out-of-hospital Cardiac Arrest (OHCA)

Treatments: Drug: propofol; Drug: esketamine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06744361

2024-515987-29-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 282 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (age ≥18 years) AND
• resuscitated OHCA of presumed cardiac cause with a shockable first recorded heart rhythm AND
• mean arterial pressure (MAP) >40 mmHg AND
• a decision to perform prehospital intubation.

Exclusion criteria

• Advanced life support termination-of-resuscitation (TOR) criteria met
• Systolic blood pressure >190 mmHg
• Known allergy to ketamine or propofol
• Chronic diseases making 180-day survival unlikely
• Body temperature <30° C.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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282 participants in 2 patient groups

S-ketamin

Experimental group

Description:

Intravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine

Treatment:

Drug: esketamine hydrochloride

Propofol

Active Comparator group

Description:

Prehospital intravenous or intraosseous bolus administration of a minimum dose of 0.25 mg/kg propofol

Treatment:

Drug: propofol