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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.
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.
Age
0 - 18 years
Sex
ALL
Healthy Volunteers
No
Shanghai Children's Medical Center, Shanghai Jiaotong University
Shanghai, China
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong
Hospital Pulau Pinang
George Town, Malaysia
Hospital Sultanah Aminah Johor Bahru
Johor Bahru, Malaysia
Hospital Tengku Ampuan Rahimah
Klang, Malaysia
Hospital Tunku Azizah (Hospital Wanita dan Kanak-Kanak Kuala Lumpur)
Kuala Lumpur, Malaysia
UKM: Hospital Tunku Ampuan Besar Tuanku Aishah Rohani
Kuala Lumpur, Malaysia
University Malaya Medical Centre (UMMC)
Kuala Lumpur, Malaysia
Hospital Umum Sarawak
Kuching, Malaysia
Hospital Sultan Idris Shah
Serdang, Malaysia
Start Date
February 1, 2026
Primary Completion Date
June 1, 2028
Completion Date
December 1, 2028
Last Updated
February 11, 2026
40,000
ESTIMATED participants
Application of the Phoenix Sepsis Score
OTHER
Lead Sponsor
KK Women's and Children's Hospital
Collaborators
NCT06650501
NCT05488340
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04929028