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Clinical Trials/NCT06460480
NCT06460480
Completed
Not Applicable

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

Haseki Training and Research Hospital1 site in 1 country44 target enrollmentJune 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Arrest
Sponsor
Haseki Training and Research Hospital
Enrollment
44
Locations
1
Primary Endpoint
late mortality
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2024
End Date
January 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Haseki Training and Research Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • supression ratio(from the first hour of intensive care admission until 48 hour)
  • oxyhemoglobin deoxyhemoglobin ratio(from the first hour of intensive care admission until 48 hour)
  • serum biomarkers(post-cardiac arrest 24th hour)

Study Sites (1)

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