Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06776302

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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