Actively Recruiting
KETamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest (OHCA) - the KETOHCA Trial
Led by Christian Hassager · Updated on 2024-12-20
282
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Out-of-hospital cardiac arrest (OHCA) is a life-threatening emergency often leading to brain injury due to lack of oxygen and blood flow. Despite improvements in resuscitation, survivors frequently face poor neurological outcomes. This trial investigates whether using ketamine as a sedative after OHCA can provide better brain protection compared to the commonly used sedative propofol. The study is a phase 2 randomized trial aiming to find a more effective neuroprotective approach for these patients. Participants will receive either intravenous or intraosseous bolus doses of ketamine at a minimum of 0.5 mg/kg or propofol at a minimum of 0.25 mg/kg during the prehospital phase following resuscitation. The study compares these two sedatives to assess their effects on brain injury markers and neurological recovery. The trial includes a quadruple masking design to ensure unbiased results. During the study, researchers will measure neuron-specific enolase levels 48 hours after cardiac arrest to assess brain cell injury. They will also evaluate neurological outcomes using the modified Rankin Score and Cerebral Performance Categories at discharge, 180 days, and 240 days after OHCA. Death from any cause will be monitored up to 180 days post-arrest. Participants will be closely followed to understand the long-term effects of the sedatives on brain function and survival.
CONDITIONS
Brief Title
Ketamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Resuscitated out-of-hospital cardiac arrest of presumed cardiac cause with a shockable first recorded heart rhythm
- Mean arterial pressure greater than 40 mmHg
- Decision to perform prehospital intubation
You will not qualify if you...
- Advanced life support termination-of-resuscitation criteria met
- 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single administration during prehospital care
Participants receive a single prehospital intravenous or intraosseous bolus of either esketamine or propofol following out-of-hospital cardiac arrest.
1 treatment event (prehospital)
Duration - Up to 240 days after cardiac arrest
Participants are monitored for neurological outcomes and survival after treatment.
Assessments at 48 hours, 2 weeks (at discharge), 180 days, and 240 days
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
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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