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NCT Number: NCT06744361

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Cardiology, Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esketamine hydrochloride

Drug

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

Propofol

Drug

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

Primary outcomes

  1. Neuron-specific enolase (NSE) measured 48 hours after OHCA

    Time frame: 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 outcomes

  1. Death from any cause

    Time frame: 180 days after cardiac arrest

    Death from any cause 180 days after cardiac arrest

  2. Neurological outcome: modified Rankin Score (mRS)

    Time frame: At 2 weeks (at discharge)

    Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms.

  3. Neurological outcome: Cerebral Performance Categories (CPC)

    Time frame: At 2 weeks (at discharge)

    Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function).

  4. Neurological outcome: modified Rankin Score (mRS)

    Time frame: At 180 days after OHCA.

    Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms.

  5. Neurological outcome: modified Rankin Score (mRS)

    Time frame: At 240 days after OHCA.

    Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms.

  6. Neurological outcome: Cerebral Performance Categories (CPC)

    Time frame: At 180 days after OHCA.

    Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function).

  7. Neurological outcome: Cerebral Performance Categories (CPC)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Salma Charabi, MD

CONTACT

[email protected]

35450572

Sponsors and collaborators

Lead sponsor

Christian Hassager

Other

Registry information

Official study title

KETamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest (OHCA) - the KETOHCA Trial

Acronym: KETOHCA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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