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

NCT ID: NCT06460480

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-15

Study Completion Date

2025-01-01

Brief Summary

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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

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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.

Conditions

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Cardiac Arrest EEG With Periodic Abnormalities Hypoxic-Ischemic Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haseki Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Berna Caliskan, MD

Role: STUDY_DIRECTOR

Haseki Training and Research Hospital Anesthesiology and Reanimation Department

Muhammet Ali Gök

Role: PRINCIPAL_INVESTIGATOR

Haseki Training and Research Hospital Anesthesiology and Reanimation Department

Locations

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Haseki Training and Research Hospital

Istanbul, Sultangazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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El-Seify M, Shata MO, Salaheldin S, Bawady S, Rezk AR. Evaluation of Serum Biomarkers and Electroencephalogram to Determine Survival Outcomes in Pediatric Post-Cardiac-Arrest Patients. Children (Basel). 2023 Jan 18;10(2):180. doi: 10.3390/children10020180.

Reference Type BACKGROUND
PMID: 36832309 (View on PubMed)

Calderone A, Jarry S, Couture EJ, Brassard P, Beaubien-Souligny W, Momeni M, Liszkowski M, Lamarche Y, Shaaban-Ali M, Matta B, Rochon A, Lebon JS, Ayoub C, Martins MR, Courbe A, Deschamps A, Denault AY. Early Detection and Correction of Cerebral Desaturation With Noninvasive Oxy-Hemoglobin, Deoxy-Hemoglobin, and Total Hemoglobin in Cardiac Surgery: A Case Series. Anesth Analg. 2022 Dec 1;135(6):1304-1314. doi: 10.1213/ANE.0000000000006155. Epub 2022 Nov 16.

Reference Type BACKGROUND
PMID: 36097147 (View on PubMed)

Dilmen OK, Meco BC, Evered LA, Radtke FM. Postoperative neurocognitive disorders: A clinical guide. J Clin Anesth. 2024 Feb;92:111320. doi: 10.1016/j.jclinane.2023.111320. Epub 2023 Nov 8.

Reference Type BACKGROUND
PMID: 37944401 (View on PubMed)

Other Identifiers

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159-2023

Identifier Type: -

Identifier Source: org_study_id

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