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MortalityEWSsGerNCT07577349

EWSs and 28-Day Mortality in Geriatric ED Patients

An observational study of Mortality and Clinical Deterioration, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Demographic Characteristics, Comorbidities and Vital Signs
How many people
2,744 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2025to 29 Jan 2026
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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.

Who may be able to join

  • Participants will be eligible for inclusion if they meet all of the following criteria:
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Known hematologic malignancy
  • Presentation for palliative support only
  • Inability to obtain informed consent from the patient or a legal representative

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Haseki Training and Research Hospital

    Istanbul, Istanbul, 34265

Other trials in Turkey (Türkiye)

About this study

Official title: Performance of Different Early Warning Systems in Predicting 28-day Mortality Among Geriatric Emergency Department Patients

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.

Read the detailed description

Emergency departments are high-acuity clinical settings in which early recognition of patients at risk of deterioration is essential. Early warning scores are widely used to support risk stratification by converting abnormalities in physiological parameters into structured clinical scores. However, the prognostic performance of these tools may be limited in older adults because of age-related physiological changes, reduced physiological reserve, atypical clinical presentation, polypharmacy, and high comorbidity burden.

This prospective, single-center observational cohort study was conducted in the emergency department of Haseki Training and Research Hospital, Istanbul, Türkiye. Consecutive patients aged 65 years and older who presented with non-traumatic conditions were screened for eligibility. Data were recorded in real time using a standardized case report form. The evaluated early warning scores included the National Early Warning Score, National Early Warning Score 2, Modified Early Warning Score, quick Sequential Organ Failure Assessment, Systemic Inflammatory Response Syndrome criteria, Rapid Emergency Medicine Score, Hamilton Early Warning Score, Triage Early Warning Score, Rapid Acute Physiology Score, and Cardiac Arrest Risk Triage score. The Clinical Frailty Scale was also assessed.

The primary objective was to evaluate the ability of these scores to predict 28-day all-cause mortality. Secondary analyses assessed comparative score performance and explored whether advanced age, comorbidity burden, frailty, laboratory parameters, and hemodynamic variables were independently associated with mortality.

Being tested
Demographic Characteristics, Comorbidities, Vital Signs, Laboratory Parameters, Severity Scores
Keywords
Early warning systems, geriatric patients, 28-day mortality, frailty
Medical subject headings
Clinical Deterioration, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Demographic CharacteristicsOther

    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.

  • ComorbiditiesOther

    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.

  • Vital SignsOther

    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.

  • Laboratory ParametersOther

    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).

  • Severity ScoresOther

    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.

  • Clinical Frailty ScaleOther

    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.

  • Early Warning ScoresOther

    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.

Study groups in NCT07577349
Study groupRoleWhat they receive
SurvivorsSurvivors were defined as eligible geriatric emergency department patients who remained alive within 28 days after the index emergency department presentation.
Receives: Other: Demographic Characteristics; Other: Comorbidities; Other: Vital Signs; Other: Laboratory Parameters; Other: Severity Scores; Other: Clinical Frailty Scale; Other: Early Warning Scores
Non-survivorsNon-survivors were defined as eligible geriatric emergency department patients who experienced all-cause mortality within 28 days after the index emergency department presentation.
Receives: Other: Demographic Characteristics; Other: Comorbidities; Other: Vital Signs; Other: Laboratory Parameters; Other: Severity Scores; Other: Clinical Frailty Scale; Other: Early Warning Scores

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At emergency department presentation, with outcome assessment at 28 days

Secondary outcomes (3)
  1. Diagnostic Performance Measures of Early Warning Score Cut-Off Values

    Sensitivity, specificity, positive predictive value, and negative predictive value will be calculated for relevant cut-off values of the evaluated early warning scores for predicting 28-day all-cause mortality.

    Measured: At emergency department presentation, with outcome assessment at 28 days

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

    The independent association of demographic variables, comorbidities, frailty, vital signs, laboratory parameters, and early warning scores with 28-day all-cause mortality will be assessed using multivariable logistic regression analysis.

    Measured: At emergency department presentation, with outcome assessment at 28 days

  3. Effect of Frailty on 28-Day Mortality Prediction

    Frailty will be assessed using the Clinical Frailty Scale, and its association with 28-day all-cause mortality will be evaluated. The incremental clinical relevance of frailty in geriatric risk stratification will also be explored.

    Measured: At emergency department presentation, with outcome assessment at 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2026
  2. Study start1 Jul 2025
  3. Primary completion29 Jan 2026
  4. Study completion29 Jan 2026

Resources

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
2,744 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07577349
Sponsor's protocol ID
01/2025
Acronym
EWSsGer
Status last verified
May 2026
First submitted
3 May 2026
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Stored in non-publicly avaliableAvaliable on request

Publications

  • 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.

    PubMed 41047463
  • 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.

    PubMed 32252135
  • 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.

    PubMed 37331563
  • 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.

    PubMed 32434791
  • 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.

    PubMed 35298560

Questions about this trial

What is this clinical trial studying?

An observational study of Mortality and Clinical Deterioration, 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 7 inclusion and 9 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 11 May 2026. 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?

Discriminatory Performance of Early Warning Scores for 28-Day Mortality (time frame: At emergency department presentation, with outcome assessment at 28 days). 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 NCT07577349, which also lists 5 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 11 May 2026.

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