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

Phase 2

Recruiting

• Conditions: Out-of-hospital Cardiac Arrest (OHCA)
• Interventions: Drug: esketamine hydrochloride; Drug: propofol

• Registration Number: NCT06744361
• Lead Sponsor: Christian Hassager

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study Start: 2024-12-12
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 282

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-ketamin	esketamine hydrochloride	Intravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine
Propofol	propofol	Prehospital intravenous or intraosseous bolus administration of a minimum dose of 0.25 mg/kg propofol

Primary Outcome Measures

Name	Time	Method
Neuron-specific enolase (NSE) measured 48 hours after OHCA	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

Secondary Outcome Measures

Name	Time	Method
Death from any cause	180 days after cardiac arrest	Death from any cause 180 days after cardiac arrest
Neurological outcome: modified Rankin Score (mRS)	At 240 days after OHCA.	Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms.
Neurological outcome: Cerebral Performance Categories (CPC)	At 240 days after OHCA.	Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function).

Trial Locations

Locations (2)

Department of Cardiology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense C, Denmark