NCT05584098

Brief Summary

In the development of sepsis treatment of recent years, the demand for medical manpower has increased significantly when patients with sepsis appear because of the expansion of medical care demand and shortened response time related to sepsis Due to the shortage of manpower, a more simple and easy-to-operate inspection method is adopted and artificial intelligence technology is used to assist in the evaluation. The applicability of physiological indicators MEWS, qSOFA and physiological parameters combination as sepsis screening tools in emergency department (ED) and predicting sepsis outcome in the emergency department. When patients with sepsis appear, artificial intelligence technology is used to remind the physicians to respond and administer drugs as soon as possible. This is a single-center retrospective study of a group of patients admitted to the emergency department. The medical records were reviewed, mainly based on the hospital site records and the existing vital signs of the patients. Attended a hospital emergency room between January 2020 and December 2022. Physiological numerical indicators MEWS and qSOFA were all scored to understand the distribution of sepsis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
950

participants targeted

Target at P75+ for not_applicable sepsis

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

2 active sites

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

March 20, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

October 7, 2022

Last Update Submit

August 29, 2025

Conditions

Keywords

SepsisModified Early Warning Score(MEWS)quick Sequential Organ Failure Assessment(qSOFA)emergency Medicinephysiological parameters combination

Outcome Measures

Primary Outcomes (3)

  • qSOFA used in emergency medicine department

    The qSOFA score is a simple score consisting of three items: respiratory rate (RR) ≥ 22 breaths per minute, altered mentation (Glasgow Coma Scale \[GCS\] \< 15), and systolic blood pressure (SBP) \< 100 mmHg and lowest score is 1 and highest is 3. The more score will show more severe disease. MEWS score:Description Risk of death or ICU admission \<3: patient in a stable condition, 3-4: Signs of respiratory failure. Consider higher level of care, ≥5: Patient in a critical condition. Higher level of care recommended

    From date of randomization until the date of first documented progression assessed up to 36 months

  • Modified Early Warning Score(MEWS) which quickly determine whether a particular patient needs increased medical attention

    MEWS score = Systolic blood pressure + Heart rate + Urine output + Respiratory rate + Temperature + AVPU. The lowest score is 0 and highest score is 14. The more score will show more severe disease. MEWS score:Description Risk of death or ICU admission \<3: patient in a stable condition, 3-4: Signs of respiratory failure. Consider higher level of care, ≥5: Patient in a critical condition. Higher level of care recommended

    From date of randomization until the date of first documented progression assessed up to 36 months

  • physiological parameters combination

    Shock Index (SI) = Heart Rate / Systolic Blood Pressure Age-Adjusted Shock Index (Age SI) = Age x Shock Index Respiratory-Adjusted Shock Index (RASI) = HR/SBP × (RR/10)

    From date of randomization until the date of first documented progression assessed up to 36 months

Study Arms (1)

qSOFA, MEWS and physiological parameters combination

OTHER

Modified Early Warning Score(MEWS), quick Sequential Organ Failure Assessment(qSOFA) and physiological parameters combination are used in prediction of occurrence of sepsis

Other: qSOFA, MEWS and physiological parameters combination

Interventions

qSOFA ,MEWS and physiological parameters combination used in emergency medicine department could be helpful in the identification of the occurrence of sepsis

qSOFA, MEWS and physiological parameters combination

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • This is a single-center retrospective study of a group of patients admitted to the emergency department.

You may not qualify if:

  • Patients with incomplete treatment clinical data, lack of information in medical records, trauma patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Martin De Porres Hospital

Chiayi City, 600046, Taiwan

Location

St. Martin De Porres Hospital

Chiayi City, 60069, Taiwan

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chia-Hsi Chen, MD

    Emergency Medicine Department of St. Martin De Porres Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Mask all identified labels in all raw data
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: In a cross-sectional study, the investigator measures the outcome and the exposures in the study participants at the same time.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician,emergency medicine department

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 18, 2022

Study Start

March 20, 2022

Primary Completion

June 10, 2023

Study Completion

September 30, 2023

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) is not available to other researchers

Locations