- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07577349
EWSs and 28-Day Mortality in Geriatric ED Patients (EWSsGer)
Performance of Different Early Warning Systems in Predicting 28-day Mortality Among Geriatric Emergency Department Patients
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Istanbul
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Istanbul, Istanbul, Turecko (Türkiye), 34265
- Haseki Training and Research Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
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
Exclusion Criteria:
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Survivors
Survivors were defined as eligible geriatric emergency department patients who remained alive within 28 days after the index emergency department presentation.
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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.
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 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.
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-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.
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 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.
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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.
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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.
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 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.
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-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.
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 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Discriminatory Performance of Early Warning Scores for 28-Day Mortality
Časové okno: At emergency department presentation, with outcome assessment at 28 days
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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.
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At emergency department presentation, with outcome assessment at 28 days
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Diagnostic Performance Measures of Early Warning Score Cut-Off Values
Časové okno: At emergency department presentation, with outcome assessment at 28 days
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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.
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At emergency department presentation, with outcome assessment at 28 days
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Independent Predictors of 28-Day Mortality in Geriatric Emergency Department Patients
Časové okno: At emergency department presentation, with outcome assessment at 28 days
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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.
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At emergency department presentation, with outcome assessment at 28 days
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Effect of Frailty on 28-Day Mortality Prediction
Časové okno: At emergency department presentation, with outcome assessment at 28 days
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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.
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At emergency department presentation, with outcome assessment at 28 days
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Adem Az, Sultangazi Haseki Eğitim ve Araştırma Hastanesi, Başhekimlik
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Patologické procesy
- Atributy nemoci
- Progrese onemocnění
- Patologické stavy, příznaky a symptomy
- Křehkost
- Klinické zhoršení
- Organizace a správa
- Správa zdravotnických služeb
- Kvalita zdravotní péče, přístup a hodnocení
- Vyšetřovací techniky
- Epidemiologické metody
- Sběr dat
- Mechanismy hodnocení zdravotní péče
- Kvalita zdravotní péče
- Veřejné zdraví
- Životní prostředí a veřejné zdraví
- Zdravotní průzkumy
- Průzkumy a dotazníky
- Evidence
- Epidemiologické faktory
- Závažnost indexu nemocí
- Ostrost pacienta
- Ukazatele zdravotního stavu
- Lékařské záznamy
- Trauma Severity Indices
- Komorbidita
- Injury Severity Score
- Early Warning Score
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