Early Sepsis Recognition Tool (SORT)

August 4, 2026 updated by: Chong Shu-Ling, KK Women's and Children's Hospital

Sepsis Optimal Recognition Toolkit in Children (SORT): An Early Recognition Tool for Children in Asia

This study seeks to develop early recognition tools specially designed for children meeting the Phoenix definition and explore implementation science aspects by investigating facilitators and barriers to adopting Phoenix sepsis criteria in clinical practice. This addresses the critical need for systemic, evidence-based approaches to paediatric sepsis identification across diverse healthcare settings in Asia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

SPECIFIC AIMS AND HYPOTHESES Specific Aim 1: Among children < 18 years old with suspected infection hospitalised in participating Pediatric Acute & Critical Care Medicine Asian Network sites, the investigators seek to compare mortality risk among those with a Phoenix sepsis score of ≥ 2 against those with a score < 2.

Hypothesis 1: The investigators hypothesize that that in-hospital mortality (%) will increase at least 5-times in both higher-resource and lower-resource sites when children with suspected infection have a Phoenix sepsis score of ≥ 2 (compared to those with a score of <2). This is based on published Phoenix data.

Specific Aim 2: The investigators aim to derive and validate the Sepsis Optimal Recognition Toolkit in children (SORT) among children (< 18 years old) with suspected infection in both higher-resource and lower-resource sites in the Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN).

Hypothesis 2: The investigators hypothesize that SORT will perform with a sensitivity of 90% and a c-statistic of at least 0.80 in predicting for sepsis as defined by a Phoenix Sepsis Score ≥ 2.

Specific Aim 3: The investigators seek to understand the feasibility and acceptability of implementing the Phoenix criteria across PACCMAN sites.

Hypothesis 3: The investigators hypothesize that the parameters required by the Phoenix sepsis score will be feasible and that clinicians and patients will find it acceptable to apply in routine practice.

Exploratory Aim: The investigators aim to study the mimickers of sepsis among children < 18 years old with a Phoenix sepsis score of ≥ 2.

Hypothesis (Exploratory): The investigators hypothesize that children with tissue hypoperfusion from cardiac, hypovolemia and toxicology causes will fulfil Phoenix criteria and mimic sepsis.

Study Type

Observational

Enrollment (Estimated)

40000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Not yet recruiting
        • Shanghai Children's Medical Center, Shanghai Jiaotong University
        • Contact:
  • Hong Kong
      • Hong Kong, Hong Kong
        • Not yet recruiting
        • Prince of Wales Hospital, the Chinese University of Hong Kong
        • Contact:
  • Malaysia
      • George Town, Malaysia
      • Johor Bahru, Malaysia
        • Not yet recruiting
        • Hospital Sultanah Aminah Johor Bahru
        • Contact:
      • Klang, Malaysia
      • Kuala Lumpur, Malaysia
        • Not yet recruiting
        • Hospital Tunku Azizah (Hospital Wanita dan Kanak-Kanak Kuala Lumpur)
        • Contact:
      • Kuala Lumpur, Malaysia
        • Not yet recruiting
        • UKM: Hospital Tunku Ampuan Besar Tuanku Aishah Rohani
        • Contact:
      • Kuala Lumpur, Malaysia
        • Not yet recruiting
        • University Malaya Medical Centre (UMMC)
        • Contact:
      • Kuching, Malaysia
        • Not yet recruiting
        • Hospital Umum Sarawak
        • Contact:
      • Serdang, Malaysia
        • Not yet recruiting
        • Hospital Sultan Idris Shah
        • Contact:
  • Pakistan
      • Karachi, Pakistan
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Not yet recruiting
        • King Abdullah Specialist Children's Hospital
        • Contact:
  • Singapore
      • Singapore, Singapore
      • Singapore, Singapore, 229899
        • Recruiting
        • KK Women's and Children' Hospital
        • Contact:
  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Szu-han Chen Dr
        • Contact:
      • Taipei, Taiwan
        • Not yet recruiting
        • Chang Gong Memorial Hospital
        • Contact:
  • Thailand
      • Bangkok, Thailand
        • Recruiting
        • King Chulalongkorn Memorial Hospital
        • Contact:
      • Bangkok, Thailand
        • Not yet recruiting
        • Ramathibodi Hospital, Mahidol University
        • Contact:
  • Vietnam
      • Hanoi, Vietnam
        • Not yet recruiting
        • The National Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children < 18 years old with suspected infection. Suspected infection is defined as children who undergo blood cultures and receive broad-spectrum anti-microbial agents in the first 24 hours of admission. Anti-microbial agents include antibiotics, antiviral, antifungal and antimalarial medications.

Description

Inclusion Criteria:

  • Children < 18 years old
  • Suspected infection defined by (1) blood culture performed (irrespective of result), AND (2) use of broad-spectrum anti-microbial agents, in the first 24 hours of admission

Exclusion Criteria:

  • 18 years and older
  • Patients who discharge At Own Risk (AOR) without outcome data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective Cohort
ARM 1: Retrospective cohort study of children hospitalised with suspected infection from 1st January 2020 to 31st December 2025, among participating sites of the Pediatric Acute & Critical Care Medicine Asian Network (PACCMAN).
Other: Application of the Phoenix Sepsis Score
Data Variables in the first 24 hours of hospital admission as per Phoenix Sepsis Score: Including that of respiratory function (PaO2:FiO2 and SpO2:FiO2 ratios, need for oxygen, high-flow, non-invasive or mechanical ventilation support), cardiovascular function (including need for vasoactive medications, lactate value and mean arterial pressure), coagulopathy (measured using platelets, International Normalized Ratio, D-dimer and Fibrinogen), neurologic dysfunction (measured with Glasgow Coma Scale and presence of fixed pupils), endocrine (blood glucose), immunologic (absolute neutrophil and absolute lymphocyte count), renal (creatinine levels) and hepatic (total bilirubin and alanine transaminase). Data from the Emergency Departments will need to be linked to inpatient records to obtain the worst values in each domain that occurred in the first 24 hours.
Prospective Cohort
ARM 2: Prospective cohort study of children hospitalised with suspected infection from 1st February 2026 to 30th June 2028, among participating sites of the Pediatric Acute & Critical Care Medicine Asian Network (PACCMAN)
Other: Application of the Phoenix Sepsis Score
Data Variables in the first 24 hours of hospital admission as per Phoenix Sepsis Score: Including that of respiratory function (PaO2:FiO2 and SpO2:FiO2 ratios, need for oxygen, high-flow, non-invasive or mechanical ventilation support), cardiovascular function (including need for vasoactive medications, lactate value and mean arterial pressure), coagulopathy (measured using platelets, International Normalized Ratio, D-dimer and Fibrinogen), neurologic dysfunction (measured with Glasgow Coma Scale and presence of fixed pupils), endocrine (blood glucose), immunologic (absolute neutrophil and absolute lymphocyte count), renal (creatinine levels) and hepatic (total bilirubin and alanine transaminase). Data from the Emergency Departments will need to be linked to inpatient records to obtain the worst values in each domain that occurred in the first 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of Phoenix Sepsis Score in Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN) sites in Asia
Time Frame: 2 years
Following Specific Aim 1: The primary outcome measure is to validate the Phoenix Sepsis Score in PACCMAN sites in Asia, with the clinical outcome of Mortality. The performance will be measured using area under the receiver operating characteristic curve (AUROC).
2 years
Derivation of an early recognition tool called Sepsis Optimal Recognition Toolkit in children (SORT)
Time Frame: 2 years
Following the second specific Aim, the outcome is for the model SORT to be derived with a sensitivity of 90% and a c-statistic of at least 0.80 in predicting for sepsis as defined by a Phoenix Sepsis Score ≥ 2.
2 years
Performance of Phoenix Sepsis Score in Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN) sites in Asia
Time Frame: 2 years

Following Specific Aim 1: The primary outcome measure is to validate the Phoenix Sepsis Score in PACCMAN sites in Asia, with the clinical outcome of Mortality. The performance will be measured using area under precision recall curve (AUPRC).

The investigators will also measure the performance using sensitivity, specificity, positive and negative predictive values.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Collaborators

National Medical Research Council (NMRC), Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-2640
  • HCSAINV25jan-0001 (Other Grant/Funding Number: National Medical Research Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data dictionaries, aggregate data and analytical plan can be shared with investigators who submit their requests to the Responsible Party with a reasonable request.

IPD Sharing Time Frame

Start Date: December 2028 End Date: December 2029

IPD Sharing Access Criteria

Researchers should submit the request to the Responsible Party listed in this study. Data dictionaries, aggregate data and analytical plan can be shared.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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