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

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06460480
• Other study ID #: 159-2023
• Status: Recruiting
• Start date: June 15, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: June 2024
• Source: Haseki Training and Research Hospital
• Contact: Berna Caliskan, MD
• Phone: +905067108770
• Email: caliskan.b[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 30, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Cardiac Arrest
• EEG With Periodic Abnormalities
• Heart Arrest
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy

Locations

Country	Name	City	State
Turkey	Haseki Training and Research Hospital	Istanbul	Sultangazi

Sponsors (1)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early mortality	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
Primary	late mortality	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	supression ratio	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
Secondary	oxyhemoglobin deoxyhemoglobin ratio	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
Secondary	serum biomarkers	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