NCT06460480

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 19, 2025

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 11, 2024

Last Update Submit

March 17, 2025

Conditions

Keywords

post-cardiac arrestelectroencephalogramcerebral oxymetrybiomarkersbrain injury

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • supression ratio

    from the first hour of intensive care admission until 48 hour

  • oxyhemoglobin deoxyhemoglobin ratio

    from the first hour of intensive care admission until 48 hour

  • serum biomarkers

    post-cardiac arrest 24th hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • experienced cardiac arrest
  • permanent spontaneous circulation is maintained for at least 48 hours after CPR
  • immediate intensive care follow-up after cardiac resuscitation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 36832309BACKGROUND
  • 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.

    PMID: 36097147BACKGROUND
  • 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.

    PMID: 37944401BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 ml blood samples will be collected during routine intensive care sampling, centrifuged, and gathered to study serum biomarkers of NSE, NRGN, and TREM-2.

MeSH Terms

Conditions

Heart ArrestHypoxia-Ischemia, BrainBrain Injuries

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Berna Caliskan, MD

    Haseki Training and Research Hospital Anesthesiology and Reanimation Department

    STUDY DIRECTOR
  • Muhammet Ali Gök

    Haseki Training and Research Hospital Anesthesiology and Reanimation Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

June 15, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

March 19, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations