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NCT Number: NCT07397689

Early Sepsis Recognition Tool

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.

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Key information

Conditions

Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Children's Medical Center, Shanghai Jiaotong University, Shanghai, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Application of the Phoenix Sepsis Score

Other

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.

Primary outcomes

  1. 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. 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).

    We will also measure the performance using sensitivity, specificity, positive and negative predictive values.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chong Shu-Ling Dr, MBBS, MRCPCH, MCI, MPH

CONTACT

[email protected]

65 -81211519

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • National Medical Research Council (NMRC), Singapore

Registry information

Official study title

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

Acronym: SORT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 9, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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