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

Completed

• Conditions: EEG With Periodic Abnormalities; Hypoxic-Ischemic Encephalopathy; Cardiac Arrest

• Registration Number: NCT06460480
• Lead Sponsor: Haseki Training and Research Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-14
• Study Start: 2024-06-15
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
late mortality	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
early mortality	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

Secondary Outcome Measures

Name	Time	Method
supression ratio	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
oxyhemoglobin deoxyhemoglobin ratio	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
serum biomarkers	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

Trial Locations

Locations (1)

Haseki Training and Research Hospital; 🇹🇷 Istanbul, Sultangazi, Turkey