NCT07023159

Brief Summary

This prospective study aimed to identify clinical and laboratory predictors of return of spontaneous circulation (ROSC), 28-day survival, and favorable neurological outcomes in adult patients experiencing out-of-hospital cardiac arrest (OHCA) and brought to the emergency department (ED) by emergency medical services (EMS). Specifically, the prognostic value of hematologic, biochemical, and blood gas parameters on admission was assessed for ROSC, 28-day survival, and favorable neurological recovery. Additionally, the study investigated the influence of key patient-centered and prehospital variables, including demographic features, initial cardiac rhythm, and the timeliness and type of cardiopulmonary resuscitation (CPR), defibrillation, and airway interventions, on overall survival and neurological status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
327

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

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

Study Start

First participant enrolled

May 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

May 26, 2025

Last Update Submit

June 7, 2025

Conditions

Keywords

OHCAshort-term survivalendotracheal intubationcardiopulmonary resuscitationneurological outcomes

Outcome Measures

Primary Outcomes (3)

  • Number of Participants with Return of Spontaneous Circulation (ROSC)

    ROSC was defined as the return of sustained spontaneous perfusing rhythm lasting at least 20 minutes without the need for external chest compressions.

    Assessed within the first 20 minutes after emergency department admission.

  • Number of Participants Alive at Day 28

    Survival was assessed as the patient being alive at 28 days following the cardiac arrest event.

    Assessed within the first 20 minutes after emergency department admission.

  • Number of Participants with Favorable Neurological Outcome (CPC 1-2) at Day 28

    Neurological outcome was determined using the Cerebral Performance Category (CPC) scale, with a CPC score of 1 or 2 representing a favorable neurological outcome, and scores from 3 to 5 considered unfavorable, reflecting severe neurological disability, coma, or death.

    Assessed within the first 20 minutes after emergency department admission.

Secondary Outcomes (3)

  • Comparison of 28-Day Survival Rates Between Participants Who Underwent Prehospital Endotracheal Intubation and Those Who Did Not

    Assessed within the first 20 minutes after emergency department admission.

  • Comparison of Favorable Neurological Outcome Rates at Day 28 Between Participants Who Underwent Prehospital Endotracheal Intubation and Those Who Did Not

    Assessed within the first 20 minutes after emergency department admission.

  • Correlation Between Admission Serum Lactate Level and 28-Day Survival

    Assessed within the first 20 minutes after emergency department admission.

Study Arms (2)

Survivors

Survivors were defined as the patient being alive at 28 days following the cardiac arrest event.

Other: DemographicsOther: ComorbiditiesOther: Prehospital VariablesDiagnostic Test: Hematological ParametersDiagnostic Test: Biochemical ParametersDiagnostic Test: Arterial Blood Gas Parameters

Non-survivors

Non-survivors had passed away within 28 days following the cardiac arrest event.

Other: DemographicsOther: ComorbiditiesOther: Prehospital VariablesDiagnostic Test: Hematological ParametersDiagnostic Test: Biochemical ParametersDiagnostic Test: Arterial Blood Gas Parameters

Interventions

The demographic profile of each patient was documented, including age and sex, to examine potential associations with survival and neurological outcomes.

Non-survivorsSurvivors

Data on pre-existing chronic conditions were recorded, such as hypertension, diabetes mellitus, coronary artery disease, chronic kidney disease, and malignancy, in order to assess their potential impact on prognosis following OHCA.

Non-survivorsSurvivors

Several prehospital factors were evaluated, including whether the cardiac arrest was witnessed, whether bystander CPR was performed, the time from collapse to the initiation of CPR, and the time from collapse to EMS arrival. Additionally, the durations of no-flow (i.e., time without any CPR) and low-flow (i.e., time with CPR but without ROSC) were noted. The initial cardiac rhythm was categorized as ventricular fibrillation or pulseless ventricular tachycardia (VF/pVT), asystole, or pulseless electrical activity (PEA). Airway management methods used in the field were documented and classified as bag-valve-mask (BVM), supraglottic airway devices (SGAs), or endotracheal intubation (ETI). Other recorded interventions included prehospital defibrillation, administration of epinephrine (including total dosage), and use of mechanical chest compression devices. Whether ROSC was achieved prior to arrival at the emergency department was also noted.

Non-survivorsSurvivors

These included white blood cell count (WBC), hemoglobin level, platelet count, mean platelet volume (MPV), and differential counts such as neutrophils, monocytes, and eosinophils.

Non-survivorsSurvivors
Biochemical ParametersDIAGNOSTIC_TEST

Measurements included creatinine, urea, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), sodium, potassium, chloride, calcium, and troponin-I levels.

Non-survivorsSurvivors

The primary clinical outcomes recorded for each patient included return of spontaneous circulation (ROSC), 28-day survival or mortality, and neurological status, which was later assessed using the Cerebral Performance Category (CPC) scale.

Non-survivorsSurvivors

Eligibility Criteria

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

This study included 420 adult patients (aged ≥18 years) who were brought to our hospital's ED due to OHCA and who had initiated attempted resuscitation by EMS were initially screened for inclusion between May 2023 and May 2024.

You may not qualify if:

  • Patients aged \< 18 years
  • Patients with in-hospital cardiac arrest
  • Patients who have suffered cardiac arrest due to major trauma, drowning, drug overdose, or known terminal illness
  • Patients with active hematologic malignancy
  • Patients with incomplete data regarding primary outcomes or admission laboratory tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

Location

Related Publications (6)

  • Jabre P, Penaloza A, Pinero D, Duchateau FX, Borron SW, Javaudin F, Richard O, de Longueville D, Bouilleau G, Devaud ML, Heidet M, Lejeune C, Fauroux S, Greingor JL, Manara A, Hubert JC, Guihard B, Vermylen O, Lievens P, Auffret Y, Maisondieu C, Huet S, Claessens B, Lapostolle F, Javaud N, Reuter PG, Baker E, Vicaut E, Adnet F. Effect of Bag-Mask Ventilation vs Endotracheal Intubation During Cardiopulmonary Resuscitation on Neurological Outcome After Out-of-Hospital Cardiorespiratory Arrest: A Randomized Clinical Trial. JAMA. 2018 Feb 27;319(8):779-787. doi: 10.1001/jama.2018.0156.

    PMID: 29486039BACKGROUND
  • Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.

    PMID: 30167699BACKGROUND
  • Strnad M, Borovnik Lesjak V, Jerot P, Esih M. Prehospital Predictors of Survival in Patients with Out-of-Hospital Cardiac Arrest. Medicina (Kaunas). 2023 Sep 26;59(10):1717. doi: 10.3390/medicina59101717.

    PMID: 37893434BACKGROUND
  • Brooks SC, Clegg GR, Bray J, Deakin CD, Perkins GD, Ringh M, Smith CM, Link MS, Merchant RM, Pezo-Morales J, Parr M, Morrison LJ, Wang TL, Koster RW, Ong MEH; International Liaison Committee on Resuscitation. Optimizing Outcomes After Out-of-Hospital Cardiac Arrest With Innovative Approaches to Public-Access Defibrillation: A Scientific Statement From the International Liaison Committee on Resuscitation. Circulation. 2022 Mar 29;145(13):e776-e801. doi: 10.1161/CIR.0000000000001013. Epub 2022 Feb 15.

    PMID: 35164535BACKGROUND
  • Soholm H, Wachtell K, Nielsen SL, Bro-Jeppesen J, Pedersen F, Wanscher M, Boesgaard S, Moller JE, Hassager C, Kjaergaard J. Tertiary centres have improved survival compared to other hospitals in the Copenhagen area after out-of-hospital cardiac arrest. Resuscitation. 2013 Feb;84(2):162-7. doi: 10.1016/j.resuscitation.2012.06.029. Epub 2012 Jul 13.

    PMID: 22796541BACKGROUND
  • Bro-Jeppesen J, Kjaergaard J, Horsted TI, Wanscher MC, Nielsen SL, Rasmussen LS, Hassager C. The impact of therapeutic hypothermia on neurological function and quality of life after cardiac arrest. Resuscitation. 2009 Feb;80(2):171-6. doi: 10.1016/j.resuscitation.2008.09.009. Epub 2008 Dec 25.

    PMID: 19111378BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart Arrest

Interventions

DemographyComorbidity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Population CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Adem Az

    Haseki Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 26, 2025

First Posted

June 15, 2025

Study Start

May 1, 2023

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Stored in non-publicly avaliable Avaliable on request

Locations