Cardiac ArrestNCT06460480
Monitoring After Cardiac Arrest: Electroencephalogram and Cerebral Oximetry in Predicting Outcome
An observational study of Cardiac Arrest and EEG With Periodic Abnormalities, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, EEG With Periodic Abnormalities, Hypoxic-Ischemic Encephalopathy
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 1 Jan 2025
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- experienced cardiac arrest
- permanent spontaneous circulation is maintained for at least 48 hours after CPR
- immediate intensive care follow-up after cardiac resuscitation
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Sultangazi, 34000
About this study
Official title: 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.
Read the 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.
- Keywords
- post-cardiac arrest, electroencephalogram, cerebral oxymetry, biomarkers, brain injury
- Medical subject headings
- Heart Arrest, Hypoxia-Ischemia, Brain, Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
early mortality
the status of the patient as exitus or alive within seven days post cardiac arrest
Measured: from the first day of intensive care admission after cardiac resuscitation until seven days
late mortality
the status of the patient as exitus or alive within twenty eight days post cardiac arrest
Measured: from the first day of intensive care admission after cardiac resuscitation until twenty eight days
Secondary outcomes (3)
supression ratio
supression ratio is analyzed from the electroencephalogram monitorization as highest value during time frame
Measured: from the first hour of intensive care admission until 48 hour
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
Measured: from the first hour of intensive care admission until 48 hour
serum biomarkers
serum biomarkers as NSE, NRGN, TREM2 will be studied in the blood sample at 24 th hour of post cardiac arrest
Measured: post-cardiac arrest 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start15 Jun 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna Caliskan, MD, Study director, Haseki Training and Research Hospital Anesthesiology and Reanimation DepartmentMuhammet Ali Gök, Principal investigator, Haseki Training and Research Hospital Anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460480
- Sponsor's protocol ID
- 159-2023
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36832309Calderone 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.
PubMed 36097147Dilmen 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.
PubMed 37944401
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Survival Outcomes After Cardiac Arrest by Monitoring Electroencephalogram, Cerebral Oximetry and Serum Biomarkers
- ClinicalTrials.gov ID
- NCT06460480
- Acronym / sponsor ID
- 159-2023
- Keywords
- post-cardiac arrest, electroencephalogram, cerebral oxymetry, biomarkers, brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- experienced cardiac arrest
- permanent spontaneous circulation is maintained for at least 48 hours after CPR
- immediate intensive care follow-up after cardiac resuscitation
Key exclusion criteria (6 listed)
- • Patients under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
3 secondary outcomes
supression ratio
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
serum biomarkers
Time frame: post-cardiac arrest 24th hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 36832309El-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.
- Background: PubMed 36097147Calderone 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.
- Background: PubMed 37944401Dilmen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berna Caliskan, MD study director
Haseki Training and Research Hospital Anesthesiology and Reanimation Department
Muhammet Ali Gök principal investigator
Haseki Training and Research Hospital Anesthesiology and Reanimation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and EEG With Periodic Abnormalities, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early mortality (time frame: from the first day of intensive care admission after cardiac resuscitation until seven days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460480, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.