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

NCT06744361 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-515987-29-00
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 2

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.

Conditions

Out-of-hospital Cardiac Arrest (OHCA)

Outcome Measures

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

  48 hours after OHCA

Secondary Outcomes (7)

• Death from any cause

  180 days after cardiac arrest

• Neurological outcome: modified Rankin Score (mRS)

  At 2 weeks (at discharge)

• Neurological outcome: Cerebral Performance Categories (CPC)

  At 2 weeks (at discharge)

• Neurological outcome: modified Rankin Score (mRS)

  At 180 days after OHCA.

• Neurological outcome: modified Rankin Score (mRS)

  At 240 days after OHCA.

Study Arms (2)

S-ketamin

EXPERIMENTAL

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

Drug: esketamine hydrochloride

Propofol

ACTIVE COMPARATOR

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

Drug: propofol

Interventions

esketamine hydrochloride DRUG

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

S-ketamin

propofol DRUG

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

Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christian Hassager: lead

Study Sites (2)

Department of Cardiology, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Odense University Hospital

Odense C, 5000, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Propofol

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Salma Charabi, MD

CONTACT

35450572; salma.charabi@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 20, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)