Actively Recruiting
Assessment of Brain Damage Using Monitoring of Cerebral Oximetry Dynamics in Patients After Cardiac Arrest
Led by University Medical Centre Maribor · Updated on 2025-01-17
100
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Sudden cardiac arrest is a major cause of death in Europe, and the recommended treatment includes cardiopulmonary resuscitation (CPR) and defibrillation with an automated external defibrillator (AED). Successful survival depends on a chain of care that spans resuscitation and post-resuscitation treatment. This study aims to assess whether changes in brain oxygen levels, measured using cerebral oximetry, can be detected with simple tests and whether these changes align with other methods used to evaluate brain damage and neurological outcomes in patients after a primary out-of-hospital cardiac arrest. Patients will undergo two tests to monitor cerebral oxygen saturation. The first test involves a controlled infusion of a drug that raises blood pressure to increase blood flow to the brain. This infusion will be given immediately after admission and stabilization, and then repeated at 6, 12, 24, 48, and 72 hours after admission. The second test involves passively elevating the lower limbs to temporarily increase heart output and brain blood flow, performed at the same times as the infusion. Throughout hospitalization, a device will continuously monitor brain oxygen levels using near-infrared spectroscopy (NIRS). Participants will be closely monitored with cerebral oxygen saturation readings taken from enrollment until two days after admission. Researchers will also evaluate other clinical, electrophysiological, imaging, and biological assessments to compare with cerebral oxygen changes. The study will not use the test results to influence treatment decisions or predict patient outcomes. The goal is to demonstrate that these simple tests can provide meaningful data that correspond with other brain damage evaluations in this patient group.
CONDITIONS
Official Title
Assessment of Brain Damage Using Monitoring of Cerebral Oximetry Dynamics in Patients After Cardiac Arrest
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Primary out-of-hospital cardiac arrest
- Unconsciousness after return of spontaneous circulation with Glasgow Coma Scale of 8 points or less
You will not qualify if you...
- Intracranial hemorrhage (clinically suspected or confirmed by CT scan)
- Body temperature less than 32 degrees Celsius (hypothermia)
- Pregnancy
- Uncontrollable bleeding
- Uncontrollable blood pressure fluctuations
- Patient considered palliative or terminal
- Cardiac arrest caused by drowning, hypothermia, or trauma
AI-Screening
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Trial Site Locations
Total: 1 location
1
University clinical center Maribor
Maribor, Slovenia, 2000
Actively Recruiting
Research Team
R
Rok Petrovčič, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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