Sepsis epidemiology in Australian and New Zealand children (SENTINEL): protocol for a multicountry prospective observational study
Introduction Sepsis affects 25.2 million children per year globally and causes 3.4 million deaths, with an annual cost of hospitalisation in the USA of US$7.3 billion. Despite being common, severe and expensive, therapies and outcomes from sepsis have not substantially changed in decades. Variable c...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/1/e077471.full |
| _version_ | 1826806492327575552 |
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| author | Franz E Babl Simon Craig Elliot Long Ed Oakley Meredith L Borland Natalie Phillips Amit Kochar Jocelyn Neutze Stephen Hearps Shefali Jani Shane George Ben Gelbart Stuart Dalziel Arjun Rao Nathan Kuppermann Amanda Williams Fran Balamuth Eunicia Tan Scott Weiss Sonia Singh Anna Lithgow Sarah Mcnab |
| author_facet | Franz E Babl Simon Craig Elliot Long Ed Oakley Meredith L Borland Natalie Phillips Amit Kochar Jocelyn Neutze Stephen Hearps Shefali Jani Shane George Ben Gelbart Stuart Dalziel Arjun Rao Nathan Kuppermann Amanda Williams Fran Balamuth Eunicia Tan Scott Weiss Sonia Singh Anna Lithgow Sarah Mcnab |
| author_sort | Franz E Babl |
| collection | DOAJ |
| description | Introduction Sepsis affects 25.2 million children per year globally and causes 3.4 million deaths, with an annual cost of hospitalisation in the USA of US$7.3 billion. Despite being common, severe and expensive, therapies and outcomes from sepsis have not substantially changed in decades. Variable case definitions, lack of a reference standard for diagnosis and broad spectrum of disease hamper efforts to evaluate therapies that may improve sepsis outcomes. This landscape analysis of community-acquired childhood sepsis in Australia and New Zealand will characterise the burden of disease, including incidence, severity, outcomes and cost. Sepsis diagnostic criteria and risk stratification tools will be prospectively evaluated. Sepsis therapies, quality of care, parental awareness and understanding of sepsis and parent-reported outcome measures will be described. Understanding these aspects of sepsis care is fundamental for the design and conduct of interventional trials to improve childhood sepsis outcomes.Methods and analysis This prospective observational study will include children up to 18 years of age presenting to 12 emergency departments with suspected sepsis within the Paediatric Research in Emergency Departments International Collaborative network in Australia and New Zealand. Presenting characteristics, management and outcomes will be collected. These will include vital signs, serum biomarkers, clinician assessment of severity of disease, intravenous fluid administration for the first 24 hours of hospitalisation, organ support therapies delivered, antimicrobial use, microbiological diagnoses, hospital and intensive care unit length-of-stay, mortality censored at hospital discharge or 30 days from enrolment (whichever comes first) and parent-reported outcomes 90 days from enrolment. We will use these data to determine sepsis epidemiology based on existing and novel diagnostic criteria. We will also validate existing and novel sepsis risk stratification criteria, characterise antimicrobial stewardship, guideline adherence, cost and report parental awareness and understanding of sepsis and parent-reported outcome measures.Ethics and dissemination Ethics approval was received from the Royal Children’s Hospital of Melbourne, Australia Human Research Ethics Committee (HREC/69948/RCHM-2021). This included incorporated informed consent for follow-up. The findings will be disseminated in a peer-reviewed journal and at academic conferences.Trial registration number ACTRN12621000920897; Pre-results. |
| first_indexed | 2024-03-07T21:52:15Z |
| format | Article |
| id | doaj.art-4b0ff81fe4a548aa926d5c14b868d00a |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-02-16T00:09:28Z |
| publishDate | 2024-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-4b0ff81fe4a548aa926d5c14b868d00a2025-02-12T14:10:11ZengBMJ Publishing GroupBMJ Open2044-60552024-01-0114110.1136/bmjopen-2023-077471Sepsis epidemiology in Australian and New Zealand children (SENTINEL): protocol for a multicountry prospective observational studyFranz E Babl0Simon Craig1Elliot Long2Ed Oakley3Meredith L Borland4Natalie Phillips5Amit Kochar6Jocelyn Neutze7Stephen Hearps8Shefali Jani9Shane George10Ben Gelbart11Stuart Dalziel12Arjun Rao13Nathan Kuppermann14Amanda Williams15Fran Balamuth16Eunicia Tan17Scott Weiss18Sonia Singh19Anna Lithgow20Sarah Mcnab215 Emergency Department, The Royal Children`s Hospital Melbourne, Melbourne, Victoria, AustraliaClinical Sciences, Murdoch Children’s Research Institute, Parkville, Victoria, AustraliaDepartment of Emergency Medicine, The Royal Children’s Hospital, Parkville, Victoria, AustraliaClinical Sciences, Murdoch Children’s Research Institute, Parkville, Victoria, AustraliaDepartment of Emergency Medicine, Perth Children’s Hospital, Perth, Western Australia, AustraliaChild Health Research Centre, The University of Queensland, South Brisbane, Queensland, AustraliaDepartment of Emergency Medicine, Women and Children’s Hospital, Adelaide, South Australia, AustraliaKidz first Middlemore Hospital, Auckland, New ZealandDepartment of Critical Care, The University of Melbourne, Parkville, Victoria, AustraliaDepartment of Emergency Medicine, The Children’s Hospital at Westmead, Westmead, New South Wales, AustraliaDivision of Emergency Medicine and Children’s Critical Care, Gold Coast University Hospital, Gold Coast, Queensland, AustraliaClinical Sciences, Murdoch Children’s Research Institute, Parkville, Victoria, AustraliaEmergency Department, Starship Children’s Hospital, Auckland, New ZealandDepartment of Emergency Medicine, Sydney Children’s Hospital, Randwick, New South Wales, AustraliaDepartments of Emergency Medicine and Pediatrics, University of California Davis School of Medicine, Sacramento, California, USAClinical Sciences, Murdoch Children’s Research Institute, Parkville, Victoria, AustraliaDivision of Emergency Medicine, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, USAKidz first Middlemore Hospital, Auckland, New ZealandNemours Children’s Health and Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, USAClinical Sciences, Murdoch Children’s Research Institute, Parkville, Victoria, AustraliaDepartment of Paediatrics, The Royal Darwin Hospital, Tiwi, Northern Territory, AustraliaClinical Sciences, Murdoch Children’s Research Institute, Parkville, Victoria, AustraliaIntroduction Sepsis affects 25.2 million children per year globally and causes 3.4 million deaths, with an annual cost of hospitalisation in the USA of US$7.3 billion. Despite being common, severe and expensive, therapies and outcomes from sepsis have not substantially changed in decades. Variable case definitions, lack of a reference standard for diagnosis and broad spectrum of disease hamper efforts to evaluate therapies that may improve sepsis outcomes. This landscape analysis of community-acquired childhood sepsis in Australia and New Zealand will characterise the burden of disease, including incidence, severity, outcomes and cost. Sepsis diagnostic criteria and risk stratification tools will be prospectively evaluated. Sepsis therapies, quality of care, parental awareness and understanding of sepsis and parent-reported outcome measures will be described. Understanding these aspects of sepsis care is fundamental for the design and conduct of interventional trials to improve childhood sepsis outcomes.Methods and analysis This prospective observational study will include children up to 18 years of age presenting to 12 emergency departments with suspected sepsis within the Paediatric Research in Emergency Departments International Collaborative network in Australia and New Zealand. Presenting characteristics, management and outcomes will be collected. These will include vital signs, serum biomarkers, clinician assessment of severity of disease, intravenous fluid administration for the first 24 hours of hospitalisation, organ support therapies delivered, antimicrobial use, microbiological diagnoses, hospital and intensive care unit length-of-stay, mortality censored at hospital discharge or 30 days from enrolment (whichever comes first) and parent-reported outcomes 90 days from enrolment. We will use these data to determine sepsis epidemiology based on existing and novel diagnostic criteria. We will also validate existing and novel sepsis risk stratification criteria, characterise antimicrobial stewardship, guideline adherence, cost and report parental awareness and understanding of sepsis and parent-reported outcome measures.Ethics and dissemination Ethics approval was received from the Royal Children’s Hospital of Melbourne, Australia Human Research Ethics Committee (HREC/69948/RCHM-2021). This included incorporated informed consent for follow-up. The findings will be disseminated in a peer-reviewed journal and at academic conferences.Trial registration number ACTRN12621000920897; Pre-results.https://bmjopen.bmj.com/content/14/1/e077471.full |
| spellingShingle | Franz E Babl Simon Craig Elliot Long Ed Oakley Meredith L Borland Natalie Phillips Amit Kochar Jocelyn Neutze Stephen Hearps Shefali Jani Shane George Ben Gelbart Stuart Dalziel Arjun Rao Nathan Kuppermann Amanda Williams Fran Balamuth Eunicia Tan Scott Weiss Sonia Singh Anna Lithgow Sarah Mcnab Sepsis epidemiology in Australian and New Zealand children (SENTINEL): protocol for a multicountry prospective observational study BMJ Open |
| title | Sepsis epidemiology in Australian and New Zealand children (SENTINEL): protocol for a multicountry prospective observational study |
| title_full | Sepsis epidemiology in Australian and New Zealand children (SENTINEL): protocol for a multicountry prospective observational study |
| title_fullStr | Sepsis epidemiology in Australian and New Zealand children (SENTINEL): protocol for a multicountry prospective observational study |
| title_full_unstemmed | Sepsis epidemiology in Australian and New Zealand children (SENTINEL): protocol for a multicountry prospective observational study |
| title_short | Sepsis epidemiology in Australian and New Zealand children (SENTINEL): protocol for a multicountry prospective observational study |
| title_sort | sepsis epidemiology in australian and new zealand children sentinel protocol for a multicountry prospective observational study |
| url | https://bmjopen.bmj.com/content/14/1/e077471.full |
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