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

March 17, 2025 updated by: Haseki Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sultangazi
      • Istanbul, Sultangazi, Turkey, 34000
        • Haseki Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients aged 18 years and older who have experienced cardiac arrest and whose permanent spontaneous circulation is maintained for at least 48 hours after CPR

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the first day of intensive care admission after cardiac resuscitation until seven days
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
from the first day of intensive care admission after cardiac resuscitation until twenty eight days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the first hour of intensive care admission until 48 hour
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
from the first hour of intensive care admission until 48 hour
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
post-cardiac arrest 24th hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haseki Training and Research Hospital

Investigators

  • Study Director: Berna Caliskan, MD, Haseki Training and Research Hospital Anesthesiology and Reanimation Department
  • Principal Investigator: Muhammet Ali Gök, Haseki Training and Research Hospital Anesthesiology and Reanimation Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 159-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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