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

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Sudden cardiac arrest is a leading cause of death in Europe, and effective treatment includes cardiopulmonary resuscitation (CPR) and use of an automated external defibrillator (AED). The study focuses on patients who have experienced a primary out-of-hospital cardiac arrest and are unconscious after return of spontaneous circulation. It aims to investigate whether simple tests can cause changes in brain oxygen levels and whether these changes align with other methods used to assess neurological outcomes and brain damage. Participants will have a device placed to continuously monitor cerebral oxygen saturation throughout their hospital stay. Two tests will be performed: the first involves a controlled, gradual infusion of a drug (norepinephrine) to raise blood pressure and increase blood flow to the brain, given immediately upon admission and then repeated at 6, 12, 24, 48, and 72 hours after admission. The second test involves passive elevation of the lower limbs to temporarily increase cardiac output and brain blood flow, performed at the same time points. During the study, patients will be observed closely in the intensive care unit, with monitoring of cerebral oxygen saturation and other clinical parameters such as blood pressure, carbon dioxide levels, hemoglobin levels, sedation depth, and body temperature. Researchers will assess changes in cerebral oxygen saturation from enrollment through two days after admission. The study will not use the test results to change patient care, but will compare these findings to other neurological assessments to better understand brain damage after cardiac arrest. The total participation period covers the hospitalization and monitoring within the first 72 hours after admission.

CONDITIONS

Brief 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 score of 8 or less
Not Eligible

You will not qualify if you...

  • Intracranial hemorrhage (clinically suspected or confirmed by CT scan)
  • Hypothermia with body temperature less than 32 degrees Celsius
  • Pregnancy
  • Uncontrollable bleeding
  • Uncontrollable blood pressure fluctuations
  • Patient considered palliative or terminal
  • Cardiac arrest caused by drowning, hypothermia, or trauma

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 days after admission

Participants undergo tests to assess brain damage by monitoring cerebral oximetry dynamics after cardiac arrest. This includes controlled norepinephrine infusion and passive elevation of the lower extremities performed at admission and multiple times up to 72 hours after admission.

Multiple assessments immediately upon admission and at 6, 12, 24, 48, and 72 hours post-admission

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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