Clinical trial NCT06460480: Monitoring After Cardiac Arrest: Electroencephalogram and Cerebral Oximetry in Predicting Outcome
Official title: Evaluation of Survival Outcomes After Cardiac Arrest by Monitoring Electroencephalogram, Cerebral Oximetry and Serum Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
EEG With Periodic Abnormalities
Hypoxic-Ischemic Encephalopathy
Keywords: post-cardiac arrest
electroencephalogram
cerebral oxymetry
biomarkers
brain injury
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: early mortality
timeFrame: from the first day of intensive care admission after cardiac resuscitation until seven days
measure: late mortality
timeFrame: from the first day of intensive care admission after cardiac resuscitation until twenty eight days
Secondary outcomes:
measure: supression ratio
timeFrame: from the first hour of intensive care admission until 48 hour
measure: oxyhemoglobin deoxyhemoglobin ratio
timeFrame: from the first hour of intensive care admission until 48 hour
measure: serum biomarkers
timeFrame: post-cardiac arrest 24th hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
state: Sultangazi
Study officials:
affiliation: Haseki Training and Research Hospital Anesthesiology and Reanimation Department
name: Berna Caliskan, MD
role: STUDY_DIRECTOR
affiliation: Haseki Training and Research Hospital Anesthesiology and Reanimation Department
name: Muhammet Ali Gök
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.