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

Last updated: December 19, 2024
Sponsor: Christian Hassager
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

propofol

esketamine hydrochloride

Clinical Study ID

NCT06744361
2024-515987-29-00
2024-515987-29-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults (age ≥18 years) AND

  • resuscitated OHCA of presumed cardiac cause with a shockable first recorded heartrhythm AND

  • mean arterial pressure (MAP) >40 mmHg AND

  • a decision to perform prehospital intubation.

Exclusion

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

Total Participants: 282
Treatment Group(s): 2
Primary Treatment: propofol
Phase: 2
Study Start date:
December 12, 2024
Estimated Completion Date:
September 01, 2027

Connect with a study center

  • Department of Cardiology, Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense C, 5000
    Denmark

    Site Not Available

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