Health TrialsbyHealthPanel

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

ConditionOut-of-hospital Cardiac Arrest (OHCA)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChristian Hassager

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

282 Participants
are divided into 2 treatment groups
Group A: S-ketaminExperimental treatment 1 intervention
Group B: PropofolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
48 hours after OHCA

Secondary outcomes

1

Death from any cause

Death from any cause 180 days after cardiac arrest

Time frame
180 days after cardiac arrest
2

Neurological outcome: modified Rankin Score (mRS)

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

Time frame
At 2 weeks (at discharge)
3

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).

Time frame
At 2 weeks (at discharge)
4

Neurological outcome: modified Rankin Score (mRS)

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

Time frame
At 180 days after OHCA.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christian Hassager

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Source ClinicalTrials.gov
Apply now