NCT07577349

Brief Summary

This prospective observational cohort study evaluated the prognostic performance of commonly used early warning scores for predicting 28-day all-cause mortality among geriatric patients presenting to the emergency department with non-traumatic conditions. Patients aged 65 years and older were consecutively screened during the study period. Demographic characteristics, comorbidities, vital signs, level of consciousness, blood gas parameters, complete blood count parameters, frailty status, and early warning scores were recorded at emergency department presentation or within the first hour of admission. The evaluated scoring systems included National Early Warning Score (NEWS/NEWS2), Modified Early Warning Score (MEWS), quick Sequential Organ Failure Assessment (qSOFA), Rapid Emergency Medicine Score (REMS), Cardiac Arrest Risk Triage (CART), and Hamilton Early Warning Score (HEWS) score. The primary outcome was 28-day all-cause mortality. The study also examined whether age, comorbidity burden, frailty, laboratory markers, and hemodynamic parameters were independently associated with 28-day mortality in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,744

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2025

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

Study Start

First participant enrolled

July 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 3, 2026

Last Update Submit

May 3, 2026

Conditions

Keywords

Early warning systemsgeriatric patients28-day mortalityfrailty

Outcome Measures

Primary Outcomes (1)

  • Discriminatory Performance of Early Warning Scores for 28-Day Mortality

    The prognostic performance of each early warning score for predicting 28-day all-cause mortality will be evaluated using receiver operating characteristic curve analysis. The area under the curve will be calculated for each score, including NEWS, NEWS2, MEWS, qSOFA, SIRS, REMS, HEWS, TREWS, RAPS, and CART.

    At emergency department presentation, with outcome assessment at 28 days

Secondary Outcomes (3)

  • Diagnostic Performance Measures of Early Warning Score Cut-Off Values

    At emergency department presentation, with outcome assessment at 28 days

  • Independent Predictors of 28-Day Mortality in Geriatric Emergency Department Patients

    At emergency department presentation, with outcome assessment at 28 days

  • Effect of Frailty on 28-Day Mortality Prediction

    At emergency department presentation, with outcome assessment at 28 days

Study Arms (2)

Survivors

Survivors were defined as eligible geriatric emergency department patients who remained alive within 28 days after the index emergency department presentation.

Other: Demographic CharacteristicsOther: ComorbiditiesOther: Vital SignsOther: Laboratory ParametersOther: Severity ScoresOther: Clinical Frailty ScaleOther: Early Warning Scores

Non-survivors

Non-survivors were defined as eligible geriatric emergency department patients who experienced all-cause mortality within 28 days after the index emergency department presentation.

Other: Demographic CharacteristicsOther: ComorbiditiesOther: Vital SignsOther: Laboratory ParametersOther: Severity ScoresOther: Clinical Frailty ScaleOther: Early Warning Scores

Interventions

Baseline demographic characteristics were recorded at emergency department presentation. These included age and sex. Age was analyzed as a continuous variable and was also considered clinically relevant because the study population consisted of geriatric patients aged 65 years and older.

Non-survivorsSurvivors

Pre-existing comorbid conditions were recorded for each participant based on medical history and available clinical records at emergency department presentation. The assessed comorbidities included hypertension, diabetes mellitus, coronary artery disease, chronic kidney disease, heart failure, ischemic stroke, chronic obstructive pulmonary disease, and malignancy. Comorbidity status was evaluated as part of baseline clinical risk assessment.

Non-survivorsSurvivors

Initial laboratory parameters obtained during emergency department evaluation were recorded. These included blood gas parameters and complete blood count results. Laboratory variables were assessed as potential predictors of 28-day all-cause mortality and were also evaluated in relation to acute physiological deterioration and metabolic stress. Parameters included, pH, partial pressure of carbon dioxide (PaCO₂, mmHg), bicarbonate (HCO₃-, mmol/L), base excess (BE, mmol/L), leukocyte count (10³/µL), and lactate level (mmol/L).

Non-survivorsSurvivors

Severity-related clinical scores, including Glasgow Coma Scale, quick Sequential Organ Failure Assessment, and Systemic Inflammatory Response Syndrome criteria, were calculated using data obtained at emergency department presentation or within the first hour after admission. These scores were used to assess acute illness severity and early clinical deterioration risk in geriatric emergency department patients.

Non-survivorsSurvivors

Early warning scores were calculated for each participant using clinical data obtained at emergency department presentation or within the first hour after admission. These scores were evaluated for their ability to predict 28-day all-cause mortality among geriatric patients presenting to the emergency department with non-traumatic conditions. The prognostic performance of each score was assessed using receiver operating characteristic curve analysis and diagnostic performance measures. Scores included National Early Warning Score, National Early Warning Score 2, Modified Early Warning Score, Rapid Emergency Medicine Score, Cardiac Arrest Risk Triage score, Hamilton Early Warning Score, Triage Early Warning Score, and Rapid Acute Physiology Score.

Non-survivorsSurvivors

Vital signs were measured at emergency department presentation or within the first hour after admission. The recorded vital signs included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, and peripheral oxygen saturation when available. These parameters were used both as individual clinical variables and as components of early warning score calculations.

Non-survivorsSurvivors

Frailty status was assessed using the Clinical Frailty Scale at emergency department presentation. The Clinical Frailty Scale was used to evaluate baseline vulnerability and physiological reserve in older adults. Its association with 28-day all-cause mortality was examined as part of geriatric risk stratification.

Non-survivorsSurvivors

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 65 years and older presenting to the emergency department with non-traumatic conditions who met the eligibility criteria and had complete data for early warning score calculation and 28-day follow-up.

You may qualify if:

  • Age 65 years or older
  • Presentation to the emergency department during the study period
  • Non-traumatic emergency department presentation
  • Availability of clinical data required for early warning score calculation
  • Availability of 28-day follow-up data
  • Written informed consent provided by the patient or, when applicable, by a legal representative

You may not qualify if:

  • Participants will be excluded if they meet any of the following criteria:
  • Trauma-related presentation
  • Insufficient clinical data for calculation of early warning scores
  • Incomplete 28-day follow-up data
  • Presentation in cardiac arrest
  • Death within the first hour after emergency department presentation
  • Known hematologic malignancy
  • Presentation for palliative support only
  • Inability to obtain informed consent from the patient or a legal representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Istanbul, 34265, Turkey (Türkiye)

Location

Related Publications (5)

  • Baeyens H, Haegdorens F, Martens S, Abeele MEV, Wallaert S, Van Den Noortgate N, Brys ADH. Validation and performance of a geriatric early warning score (GEWS) versus the national early warning score (NEWS) in predicting clinical deterioration in frail older patients. Eur Geriatr Med. 2026 Apr;17(2):615-627. doi: 10.1007/s41999-025-01316-7. Epub 2025 Oct 6.

  • Kim I, Song H, Kim HJ, Park KN, Kim SH, Oh SH, Youn CS. Use of the National Early Warning Score for predicting in-hospital mortality in older adults admitted to the emergency department. Clin Exp Emerg Med. 2020 Mar;7(1):61-66. doi: 10.15441/ceem.19.036. Epub 2020 Mar 31.

  • Covino M, Sandroni C, Della Polla D, De Matteis G, Piccioni A, De Vita A, Russo A, Salini S, Carbone L, Petrucci M, Pennisi M, Gasbarrini A, Franceschi F. Predicting ICU admission and death in the Emergency Department: A comparison of six early warning scores. Resuscitation. 2023 Sep;190:109876. doi: 10.1016/j.resuscitation.2023.109876. Epub 2023 Jun 17.

  • Gerry S, Bonnici T, Birks J, Kirtley S, Virdee PS, Watkinson PJ, Collins GS. Early warning scores for detecting deterioration in adult hospital patients: systematic review and critical appraisal of methodology. BMJ. 2020 May 20;369:m1501. doi: 10.1136/bmj.m1501.

  • Guan G, Lee CMY, Begg S, Crombie A, Mnatzaganian G. The use of early warning system scores in prehospital and emergency department settings to predict clinical deterioration: A systematic review and meta-analysis. PLoS One. 2022 Mar 17;17(3):e0265559. doi: 10.1371/journal.pone.0265559. eCollection 2022.

MeSH Terms

Conditions

Clinical DeteriorationFrailty

Interventions

ComorbidityInjury Severity ScoreEarly Warning Score

Condition Hierarchy (Ancestors)

Disease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthTrauma Severity IndicesMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsSeverity of Illness IndexPatient AcuityHealth Status IndicatorsHealth SurveysSurveys and Questionnaires

Study Officials

  • Adem Az

    Sultangazi Haseki Eğitim ve Araştırma Hastanesi, Başhekimlik

    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 3, 2026

First Posted

May 11, 2026

Study Start

July 1, 2025

Primary Completion

January 29, 2026

Study Completion

January 29, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Stored in non-publicly avaliableAvaliable on request

Locations