Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06744361

Ketamine Sedation as a Brain Protecting Treatment After Out-of-hospital Cardiac Arrest The KETOHCA Trial Comparing Esketamine and Propofol Sedation

Led by Christian Hassager · Updated on 2024-12-20

282

Participants Needed

2

Research Sites

141 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Out-of-hospital cardiac arrest (OHCA) is a serious medical emergency often causing brain injury due to lack of oxygen. Despite improvements in resuscitation, survivors frequently face poor neurological outcomes. This phase 2 trial investigates whether ketamine, a sedative with potential brain-protective effects, can improve outcomes compared to the commonly used sedative propofol in OHCA patients. Participants will receive either esketamine hydrochloride or propofol before hospital arrival. Esketamine is given as an intravenous or intraosseous bolus at a minimum dose of 0.5 mg/kg, while propofol is administered similarly at a minimum dose of 0.25 mg/kg. The study compares these two sedation methods to evaluate their effects on brain protection after cardiac arrest. During the study, researchers will measure neuron-specific enolase (NSE), a marker of brain injury, 48 hours after the cardiac arrest. Participants' neurological outcomes and safety will be monitored to assess the treatments' impact. The trial focuses on adults who have had a resuscitated cardiac arrest with a shockable rhythm and meet specific blood pressure and clinical criteria.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Resuscitated out-of-hospital cardiac arrest with a shockable first recorded heart rhythm
  • Mean arterial pressure greater than 40 mmHg
  • Decision made to perform prehospital intubation
Not Eligible

You will not qualify if you...

  • Met advanced life support termination-of-resuscitation criteria
  • Systolic blood pressure greater than 190 mmHg
  • Known allergy to ketamine or propofol
  • Chronic diseases making 180-day survival unlikely
  • Body temperature below 30 degrees Celsius

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Department of Cardiology, Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

2

Odense University Hospital

Odense C, Denmark, 5000

Not Yet Recruiting

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Research Team

S

Salma Charabi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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