Early Sepsis Recognition Tool

Official title

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

Overview

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.

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.

Interventions

• 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 Scal

Primary outcome measures

• Performance of Phoenix Sepsis Score in Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN) sites in Asia [Time frame: 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]
• Derivation of an early recognition tool called Sepsis Optimal Recognition Toolkit in children (SORT) [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Malaysia · 8 centers

• Hospital Pulau Pinang — George Town
• Hospital Sultanah Aminah Johor Bahru — Johor Bahru
• Hospital Tengku Ampuan Rahimah — Klang
• Hospital Tunku Azizah (Hospital Wanita dan Kanak-Kanak Kuala Lumpur) — Kuala Lumpur
• UKM: Hospital Tunku Ampuan Besar Tuanku Aishah Rohani — Kuala Lumpur
• University Malaya Medical Centre (UMMC) — Kuala Lumpur
• Hospital Umum Sarawak — Kuching
• Hospital Sultan Idris Shah — Serdang

Singapore · 2 centers

• KK Women's and Children' Hospital — Singapore
• National University Hospital — Singapore

Taiwan · 2 centers

• Chang Gong Memorial Hospital — Taipei
• National Taiwan University Hospital — Taipei

Thailand · 2 centers

• King Chulalongkorn Memorial Hospital — Bangkok
• Ramathibodi Hospital, Mahidol University — Bangkok

China · 1 center

• Shanghai Children's Medical Center, Shanghai Jiaotong University — Shanghai

Hong Kong · 1 center

• Prince of Wales Hospital, The Chinese University of Hong Kong — Hong Kong

Pakistan · 1 center

• Aga Khan University — Karachi

Saudi Arabia · 1 center

• King Abdullah Specialist Children's Hospital — Riyadh

Vietnam · 1 center

• The National Children's Hospital — Hanoi

Publications

• Arabi YM, Alsaawi A, Alzahrani M, Al Khathaami AM, AlHazme RH, Al Mutrafy A, Al Qarni A, Vishwakarma RK, Al Anazi R, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Alatassi A, Al-Dorzi HM, Al-Hameed F, Babakr R, Alghamdi AA, Bin Salih S, Alharbi A, AlKatheri ME, Mustafa H, Al-Qahtani S, Al Qahtani S, Alselaim N, Tashkandi N, Alyami AH, Alyousef Z, AlDibasi O, Al-Qahtani AH, Aldawood A, Caswe PMID 39658862
• Sanchez-Pinto LN, Bennett TD, DeWitt PE, Russell S, Rebull MN, Martin B, Akech S, Albers DJ, Alpern ER, Balamuth F, Bembea M, Chisti MJ, Evans I, Horvat CM, Jaramillo-Bustamante JC, Kissoon N, Menon K, Scott HF, Weiss SL, Wiens MO, Zimmerman JJ, Argent AC, Sorce LR, Schlapbach LJ, Watson RS; Society of Critical Care Medicine Pediatric Sepsis Definition Task Force; Biban P, Carrol E, Chiotos K, Fla PMID 38245897
• Schlapbach LJ, Weiss SL, Bembea MM, Carcillo JA, Leclerc F, Leteurtre S, Tissieres P, Wynn JL, Zimmerman J, Lacroix J; Pediatric Organ Dysfunction Information Update Mandate (PODIUM) Collaborative. Scoring Systems for Organ Dysfunction and Multiple Organ Dysfunction: The PODIUM Consensus Conference. Pediatrics. 2022 Jan 1;149(1 Suppl 1):S23-S31. doi: 10.1542/peds.2021-052888D. PMID 34970683
• Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lanc PMID 31954465
• Watson RS, Carrol ED, Carter MJ, Kissoon N, Ranjit S, Schlapbach LJ. The burden and contemporary epidemiology of sepsis in children. Lancet Child Adolesc Health. 2024 Sep;8(9):670-681. doi: 10.1016/S2352-4642(24)00140-8. PMID 39142741
• Schlapbach LJ, Watson RS, Sorce LR, Argent AC, Menon K, Hall MW, Akech S, Albers DJ, Alpern ER, Balamuth F, Bembea M, Biban P, Carrol ED, Chiotos K, Chisti MJ, DeWitt PE, Evans I, Flauzino de Oliveira C, Horvat CM, Inwald D, Ishimine P, Jaramillo-Bustamante JC, Levin M, Lodha R, Martin B, Nadel S, Nakagawa S, Peters MJ, Randolph AG, Ranjit S, Rebull MN, Russell S, Scott HF, de Souza DC, Tissieres PMID 38245889

Identifiers

NCT: NCT07397689 · 2023-2640 · HCSAINV25jan-0001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗