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

NCT ID: NCT06744361

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-12

Study Completion Date

2027-09-01

Brief Summary

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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

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Conditions

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Out-of-hospital Cardiac Arrest (OHCA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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S-ketamin

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

Group Type EXPERIMENTAL

esketamine hydrochloride

Intervention Type DRUG

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

Propofol

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

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

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

Interventions

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esketamine hydrochloride

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

Intervention Type DRUG

propofol

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christian Hassager

OTHER

Sponsor Role lead

Responsible Party

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Christian Hassager

Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Cardiology, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Odense University Hospital

Odense C, , Denmark

Site Status NOT_YET_RECRUITING

Countries

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Denmark

Central Contacts

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Salma Charabi, MD

Role: CONTACT

Phone: 35450572

Email: [email protected]

Facility Contacts

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Laust R Obling, MD

Role: primary

Laust R Obling, MD

Role: backup

Salma Charabi, MD

Role: backup

Henrik Schmidt, MD

Role: primary

Henrik Schmidt, MD

Role: backup

Other Identifiers

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2024-515987-29-00

Identifier Type: CTIS

Identifier Source: secondary_id

2024-515987-29-00

Identifier Type: -

Identifier Source: org_study_id