NCT07640971

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 6, 2026

Last Update Submit

June 6, 2026

Conditions

Keywords

Acute PancreatitisIn-Hospital MortalityOlder AdultsEmergency Department Risk Stratification

Outcome Measures

Primary Outcomes (1)

  • In-Hospital Mortality

    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.

Study Arms (1)

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.

Other: Retrospective Calculation of NEWS-2 Score

Interventions

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.

Patients Aged 65 Years and Older with Acute Pancreatitis

Eligibility Criteria

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

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Antalya Training and Research Hospital

Antalya, konyaaltı, 07100, Turkey (Türkiye)

Location

Related Publications (1)

  • Tan JW, Zhang XQ, Geng CM, Peng LL. Development of the National Early Warning Score-Calcium Model for Predicting Adverse Outcomes in Patients With Acute Pancreatitis. J Emerg Nurs. 2020 Mar;46(2):171-179. doi: 10.1016/j.jen.2019.11.003. Epub 2019 Dec 19.

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Central Study Contacts

MURAT DUYAN, ASSOCIATE PROFESSOR

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2026

First Posted

June 11, 2026

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations