Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000920897
Ethics application status
Approved
Date submitted
25/05/2021
Date registered
15/07/2021
Date last updated
20/02/2024
Date data sharing statement initially provided
15/07/2021
Date results information initially provided
20/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevalence, severity, and outcomes of sepsis in Australian and New Zealand children
Scientific title
Epidemiology of paediatric community-acquired sepsis in Australia and New Zealand
Secondary ID [1] 304307 0
None
Universal Trial Number (UTN)
Trial acronym
SENTINEL (Sepsis in Australian and New Zealand Children)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 322048 0
Condition category
Condition code
Infection 319773 319773 0 0
Other infectious diseases
Public Health 320082 320082 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study of children who present to participating Emergency Departments in Australia and New Zealand and are diagnosed with or treated for sepsis. For participants, data from medical records will be collected for study purposes. Clinical outcome data will be censored at 30 days after enrolment. Functional outcome will be ascertained by the research team 90 days after enrolment using a short questionnaire. The questionnaire will be delivered separately via telephone call, email link, or text message.
Intervention code [1] 320651 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327636 0
To describe the prevalence of sepsis in Australian and New Zealand paediatric Emergency Departments. Sepsis is defined as admission diagnosis of sepsis or treatment for sepsis in the Emergency Department (admission to hospital for IV antibiotics and one or more fluid boluses).
Timepoint [1] 327636 0
The study will be conducted over a 2-year time period. During this time, all hospital admissions for sepsis will be eligible for enrolment. All patient's with an admission diagnosis of sepsis or who are treated for sepsis over this time period will be included. Patients will be identified and enrolled prospectively by their treating clinician, with data collected from the patients medical record.
Primary outcome [2] 327637 0
A composite clinical outcome will be assessed using the medical records of enrolled patients: the Paediatric hospitalisation for Organ Support Therapy (POST30) score (days on inotropes + days on mechanical ventilation + days on renal replacement therapy + days on extra-corporeal life support + days in ICU + days in hospital censored day 30 post enrolment; death = maximum score).
Timepoint [2] 327637 0
Clinical outcomes will be evaluated at hospital discharge or day 30 after enrolment, whichever comes first.
Primary outcome [3] 327960 0
Functional outcome will be assessed using the Pediatric Overall Performance Category.
Timepoint [3] 327960 0
The Pediatric Overall Performance Category will be assessed 90 days after enrolment by parents of enrolled children.
Secondary outcome [1] 396026 0
Microbiology of sepsis presenting to Australian and New Zealand Emergency Departments, including primary pathogen causing sepsis, blood culture contamination rates and bacterial resistance patterns.
Timepoint [1] 396026 0
Microbiology of sepsis will be will be collected prospectively and evaluated at hospital discharge or 30 days following admission, whichever comes first.
Secondary outcome [2] 396028 0
A composite outcome describing compliance with local sepsis guidelines assessed from the patient medical record. Aspects of care that will be evaluated include: antibiotic choice and dose, timing and route of administration; fluid bolus choice and dose, timing and route of administration; inotrope choice and dose, timing and route of administration; and concurrent therapies administered in ED (corticosteroids, IVIG, blood products).
Timepoint [2] 396028 0
Secondary outcomes will be will be collected prospectively and evaluated at hospital discharge or 30 days following admission, whichever comes first.
Secondary outcome [3] 396029 0
The test characteristics of clinical scores (including SIRS, qSOFA, qPELOD-2, pSOFA, PEWS, PIM-3, and PRISM) for use in risk stratification.
Timepoint [3] 396029 0
Risk stratification features will be collected prospectively and evaluated at hospital discharge or 30 days following admission, whichever comes first.
Secondary outcome [4] 398266 0
The test characteristics of biomarkers (including lactate, blood cell counts, creatinine, coagulation profile) for risk stratification.
Timepoint [4] 398266 0
Risk stratification features will be collected prospectively and evaluated at hospital discharge or 30 days following admission, whichever comes first

Eligibility
Key inclusion criteria
Presentation to participating hospital Emergency Department
Age less than or equal to 18 years
Treatment for sepsis (IV/IM/IO antibiotics pre-hospital or in ED, fluid bolus or inotropic support pre-hospital or in ED) OR diagnosis of sepsis in the Emergency Department
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who only receive antibiotics or circulatory support following induction of anaesthetic in the operating theater.

Patients not initially seen in the Emergency Department (transferred directly to ward or admitted via clinic)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to analyse the data. Subgroups of vulnerable children, including those of Aboriginal or Torres Strait Islander or Maori heritage, neonates, immunosuppressed children, children with central venous access devices will be analysed separately.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/04/2021
Date of last participant enrolment
Anticipated
21/04/2023
Actual
31/12/2023
Date of last data collection
Anticipated
21/07/2023
Actual
31/12/2023
Sample size
Target
1000
Accrual to date
Final
6293
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 19538 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 19539 0
Monash Children’s Hospital - Clayton
Recruitment hospital [3] 19540 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [4] 19541 0
Gold Coast University Hospital - Southport
Recruitment hospital [5] 19542 0
Sydney Children's Hospital - Randwick
Recruitment hospital [6] 19543 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [7] 19544 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [8] 19545 0
Perth Children's Hospital - Nedlands
Recruitment hospital [9] 19546 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 34147 0
3052 - Parkville
Recruitment postcode(s) [2] 34148 0
3168 - Clayton
Recruitment postcode(s) [3] 34149 0
4101 - South Brisbane
Recruitment postcode(s) [4] 34150 0
4215 - Southport
Recruitment postcode(s) [5] 34151 0
2031 - Randwick
Recruitment postcode(s) [6] 34152 0
2145 - Westmead
Recruitment postcode(s) [7] 34153 0
5006 - North Adelaide
Recruitment postcode(s) [8] 34154 0
6009 - Nedlands
Recruitment postcode(s) [9] 34155 0
0810 - Tiwi
Recruitment outside Australia
Country [1] 23722 0
New Zealand
State/province [1] 23722 0

Funding & Sponsors
Funding source category [1] 308682 0
Self funded/Unfunded
Name [1] 308682 0
n/a
Country [1] 308682 0
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children's Research Institute
Address
50 Flemington Road
Parkville, Victoria
3052
Country
Australia
Secondary sponsor category [1] 309568 0
None
Name [1] 309568 0
Address [1] 309568 0
Country [1] 309568 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308604 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 308604 0
52 Flemington Road
Parkville, Victoria
3052
Ethics committee country [1] 308604 0
Australia
Date submitted for ethics approval [1] 308604 0
22/12/2020
Approval date [1] 308604 0
06/01/2021
Ethics approval number [1] 308604 0
68569

Summary
Brief summary
Background: Sepsis is the leading cause of early childhood death worldwide, with an estimated 4 million children dying from this final common pathway for severe infections every year. The burden of disease in Australia and New Zealand is unknown, including mortality, duration of hospitalisation, requirement for intensive care and organ support therapies, and long-term functional outcome in sepsis survivors. Early markers of severe disease and predictors of poor outcome in childhood sepsis are unknown.

Sepsis-related hospital costs are estimated at $4 billion per annum for children and $12 billion per annum for adults in the United States. The cost of hospitalisation for children with sepsis in Australia and New Zealand is unknown.

Variation in guidelines for sepsis treatment in Australia and New Zealand, and adherence to such guidelines, is unknown.

The microbiology and resistance patterns of bacterial pathogens in children treated for sepsis in Australia and New Zealand are unknown. Whether current empiric antibiotic recommendations are appropriate to cover bacterial pathogens causing sepsis in Australia and New Zealand is unknown.

The prevalence and outcomes in subgroups of vulnerable, high risk children, including those receiving cancer chemotherapy, those self identifying as of Aboriginal or Torres Strait Islander or Maori ethnicity, those with chronic medical conditions, and infants or neonates who are treated for sepsis are unknown.

Rationale: Baseline observational data is required to answer fundamental aspects of sepsis care for children in Australia and New Zealand, and to plan future interventional studies.

Defining characteristics, prevalence, severity, resource utilisation, cost, variation in care, and antimicrobial stewardship are all important and unexplored components of the paediatric sepsis research landscape that will be addressed by this study.

Aim: To describe the epidemiology of hospitalised children treated for sepsis in Australia and New Zealand.
Trial website
https://www.mcri.edu.au/research/projects/sentinel
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111298 0
A/Prof Elliot Long
Address 111298 0
Emergency Department
The Royal Children's Hospital
52 Flemington Road
Parkville, Victoria
3052
Country 111298 0
Australia
Phone 111298 0
+61 425573585
Fax 111298 0
+61393456006
Email 111298 0
[email protected]
Contact person for public queries
Name 111299 0
Elliot Long
Address 111299 0
Emergency Department
The Royal Children's Hospital
52 Flemington Road
Parkville, Victoria
3052
Country 111299 0
Australia
Phone 111299 0
+61 425573585
Fax 111299 0
+61393456006
Email 111299 0
[email protected]
Contact person for scientific queries
Name 111300 0
Elliot Long
Address 111300 0
Emergency Department
The Royal Children's Hospital
52 Flemington Road
Parkville, Victoria
3052
Country 111300 0
Australia
Phone 111300 0
+61 425573585
Fax 111300 0
+61393456006
Email 111300 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified data only will be collected for this study


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11758Study protocol  [email protected]
11759Ethical approval    382060-(Uploaded-25-05-2021-12-54-20)-Study-related document.pdf
11760Informed consent form    382060-(Uploaded-25-05-2021-12-55-19)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo N/A

Documents added automatically
No additional documents have been identified.