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Completed

NCT Number: NCT06460480

Monitoring After Cardiac Arrest: Electroencephalogram and Cerebral Oximetry in Predicting Outcome

Because of its high incidence, it is essential to determine the neurological prognosis after cardiac arrest. However, there is not much information to guide post-cardiac arrest care. Also, dynamic monitoring of the state of the brain can help provide information about the patient's prognosis other than previously described serum biomarkers. Therefore, the researchers will monitor postcardiac arrest patients in the intensive care unit for 48 hours by electroencephalogram and cerebral oximetry and collect blood samples for serum biomarkers: neuron-specific enolase (NSE), human neurogranin (NRGN) and human trigger receptor expressed on myeloid cells (TREM-2), which are associated with neuronal damage. And investigate the relation of these data to mortality.

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Key information

About this study

After cardiac resuscitation and intubation, the patient will be followed up with electroencephalogram-based monitoring and cerebral oximetry in the ICU for 48 hours. As standard, post-CPR patients will be sedated with midazolam (0.02- 0.1 mg/kg/s) and remifentanil (0.25- 0.5 mcq/kg/min) for 24 hours.

Brain function measurements will be recorded under sedation for the first 24 hours and without sedation for the second 24 hours. The values recorded were suppression ratio, suppression time, patient state index, oxyhemoglobin and deoxyhemoglobin, and regional oxygen saturation. After 24 hours, a 2 ml blood sample will be taken for biomarkers (NSE, NRGN, TREM-2). Patient survival will be followed up for seven days and 28 days.

The demographic data of the patients (age, gender, body mass index, ASA scores, comorbidities, history of previous operations), blood pressure, heart rate and SpO2, CPR duration, the reason for arrest(4H/4T), and inotropic-vasopressor support before and after arrest will be recorded; GCS, APACHE-2, and SOFA scores will be recorded when the patient is first admitted to the intensive care unit and at the time of cardiac arrest.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • experienced cardiac arrest
  • permanent spontaneous circulation is maintained for at least 48 hours after CPR
  • immediate intensive care follow-up after cardiac resuscitation

Exclusion criteria

  • • Patients under 18 years of age
  • Presence of previously known neurological disease (cerebral palsy, neurodegenerative disease, encephalitis, etc.)
  • Immunosuppressive patients due to previously known hematological malignancy or solid tumor
  • Patients with a history of head trauma
  • Patients with cardiac arrest within 48 hours after spontaneous circulation is established
  • Patients sedated for more than 24 hours

Treatment and study plan

Primary outcomes

  1. early mortality

    Time frame: from the first day of intensive care admission after cardiac resuscitation until seven days

    the status of the patient as exitus or alive within seven days post cardiac arrest

  2. late mortality

    Time frame: from the first day of intensive care admission after cardiac resuscitation until twenty eight days

    the status of the patient as exitus or alive within twenty eight days post cardiac arrest

Secondary outcomes

  1. supression ratio

    Time frame: from the first hour of intensive care admission until 48 hour

    supression ratio is analyzed from the electroencephalogram monitorization as highest value during time frame

  2. oxyhemoglobin deoxyhemoglobin ratio

    Time frame: from the first hour of intensive care admission until 48 hour

    oxyhemoglobin deoxyhemoglobin ratio is a calculated value on the cerebral oximetry monitorization and recorded as the highest deoxyhemoglobine and lowest oxyhemoglobine values

  3. serum biomarkers

    Time frame: post-cardiac arrest 24th hour

    serum biomarkers as NSE, NRGN, TREM2 will be studied in the blood sample at 24 th hour of post cardiac arrest

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

Evaluation of Survival Outcomes After Cardiac Arrest by Monitoring Electroencephalogram, Cerebral Oximetry and Serum Biomarkers

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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