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Predictive Performance of NEWS-2 and NEWS-Calcium Scores for In-Hospital Mortality in Older Patients With Acute Pancreatitis (NEWS)

6 de junio de 2026 actualizado por: Antalya Health Sciences University

Comparison of the Predictive Performance of NEWS-2 and NEWS-Calcium Scores on In-Hospital Mortality in Patients Aged 65 Years and Older Diagnosed With Acute Pancreatitis in the Emergency Department.

Acute pancreatitis is an important gastrointestinal emergency that may lead to mortality, particularly in older patients. This retrospective, single-center observational prognostic validation study aims to compare the predictive performance of the National Early Warning Score 2 (NEWS-2) and NEWS-Calcium scores for in-hospital mortality in patients aged 65 years and older diagnosed with acute pancreatitis in the emergency department.

Electronic medical records of eligible patients will be reviewed retrospectively. Demographic characteristics, vital signs, serum calcium levels, clinical outcomes, intensive care unit admission, organ failure, length of hospital stay, and in-hospital mortality will be recorded. NEWS-2 will be calculated using vital parameters at admission, while the NEWS-Calcium score will be obtained by adding a calcium-based score to NEWS-2.

The primary outcome will be in-hospital mortality. Secondary outcomes will include intensive care unit admission, severe acute pancreatitis, persistent organ failure, and length of hospital stay. The predictive performances of the scores will be compared using ROC curve analysis, AUC values, and the DeLong test. This study aims to identify the most appropriate early prognostic score for older patients with acute pancreatitis and to support clinical decision-making in emergency settings.

Descripción general del estudio

Descripción detallada

Acute pancreatitis is a common gastrointestinal emergency that may be associated with significant morbidity and mortality, particularly in older patients. In individuals aged 65 years and older, reduced physiological reserve, increased comorbidity burden, and delayed clinical deterioration may make early risk stratification more important in the emergency department.

The National Early Warning Score 2 (NEWS-2) is a widely used clinical scoring system based on routinely measured physiological parameters, including respiratory rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness, temperature, and supplemental oxygen use. Calcium abnormalities, especially hypocalcemia, may also be associated with disease severity and poor outcomes in acute pancreatitis. Therefore, a calcium-integrated scoring approach may improve early prognostic assessment in this patient population.

This study is designed as a single-center, retrospective, observational prognostic validation study. The study will include patients aged 65 years and older who were admitted to the emergency department and diagnosed with acute pancreatitis during the predefined study period. Eligible patients will be identified through electronic medical records. Demographic characteristics, comorbidities, vital signs at emergency department admission, laboratory parameters including serum calcium levels, clinical outcomes, intensive care unit admission, organ failure status, length of hospital stay, and in-hospital mortality will be recorded.

The NEWS-2 score will be calculated using physiological parameters measured at the time of emergency department admission. The NEWS-Calcium score will be calculated by adding a calcium-based component to the NEWS-2 score according to serum total or corrected calcium levels. The primary outcome of the study will be in-hospital mortality. Secondary outcomes will include intensive care unit admission, development of severe acute pancreatitis, persistent organ failure, and length of hospital stay.

The main objective of this study is to compare the predictive performance of NEWS-2 and NEWS-Calcium scores for in-hospital mortality in older patients with acute pancreatitis. Receiver operating characteristic (ROC) curve analysis will be used to evaluate the prognostic performance of each score. The area under the curve (AUC), sensitivity, specificity, positive predictive value, negative predictive value, and optimal cut-off values will be calculated. The AUC values of NEWS-2 and NEWS-Calcium will be compared using the DeLong test.

This study is expected to provide evidence on whether the addition of serum calcium to NEWS-2 improves early mortality prediction in geriatric patients with acute pancreatitis. The findings may contribute to early risk stratification, clinical decision-making, and appropriate allocation of intensive care resources in the emergency department.

Tipo de estudio

De observación

Inscripción (Estimado)

350

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: MURAT DUYAN, ASSOCIATE PROFESSOR
  • Número de teléfono: +905404120735
  • Correo electrónico: drmuratduyan@gmail.com

Ubicaciones de estudio

    • konyaaltı
      • Antalya, konyaaltı, Turquía (Türkiye), 07100
        • University of Health Sciences, Antalya Training and Research Hospital
        • Contacto:
          • MURAT DUYAN, ASSOCIATE PROFESSOR
          • Número de teléfono: +905404120735
          • Correo electrónico: drmuratduyan@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

The study population will consist of patients aged 65 years and older who were admitted to the emergency department and diagnosed with acute pancreatitis during the predefined study period. Eligible patients will be identified retrospectively through electronic medical records. Patients with available admission vital signs, serum calcium levels, and in-hospital outcome data will be included. Patients with missing data required for calculation of NEWS-2 or NEWS-Calcium scores, unavailable outcome data, or transfer before outcome assessment will be excluded. Only the first eligible admission will be analyzed for patients with recurrent admissions.

Descripción

Inclusion Criteria:

  • Age 65 years or older.
  • Admission to the emergency department with a diagnosis of acute pancreatitis during the study period.
  • Diagnosis of acute pancreatitis established according to clinical presentation, serum pancreatic enzyme levels, and/or imaging findings.
  • Availability of admission vital parameters required to calculate the National Early Warning Score 2 (NEWS-2).
  • Availability of serum calcium measurement at emergency department admission.
  • Availability of in-hospital clinical outcome data.

Exclusion Criteria:

  • Age younger than 65 years.
  • Absence of a confirmed diagnosis of acute pancreatitis.
  • Missing data required to calculate NEWS-2 or NEWS-Calcium scores.
  • Missing serum calcium measurement at admission.
  • Incomplete medical records or unavailable in-hospital outcome data.
  • Transfer to another hospital before clinical outcome assessment.
  • Recurrent admissions during the study period; only the first eligible admission will be analyzed.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Patients Aged 65 Years and Older with Acute Pancreatitis
This cohort will include patients aged 65 years and older diagnosed with acute pancreatitis in the emergency department. Data will be collected retrospectively from electronic medical records. No intervention will be administered. NEWS-2 and NEWS-Calcium scores will be calculated using admission data, and their predictive performance for in-hospital mortality will be compared.
he National Early Warning Score 2 (NEWS-2) will be calculated retrospectively using physiological parameters recorded at emergency department admission, including respiratory rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness, body temperature, and supplemental oxygen use. No intervention will be administered to patients as part of this study.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
In-Hospital Mortality
Periodo de tiempo: From emergency department admission to hospital discharge or in-hospital death, up to 30 days.
n-hospital mortality will be defined as death occurring during the index hospitalization among patients aged 65 years and older diagnosed with acute pancreatitis in the emergency department. Mortality status will be obtained retrospectively from electronic medical records.
From emergency department admission to hospital discharge or in-hospital death, up to 30 days.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de julio de 2026

Finalización primaria (Estimado)

15 de septiembre de 2026

Finalización del estudio (Estimado)

15 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

6 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de junio de 2026

Publicado por primera vez (Actual)

11 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared. This is a retrospective study based on electronic medical records, and individual-level patient data will not be made available to other researchers due to confidentiality, ethical, and institutional data protection regulations. Only aggregated and anonymized study results will be reported.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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