Overview

Why do we need the SENTINEL Study?

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 outcomes 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 likely substantial.

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

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 Māori ethnicity, those with chronic medical conditions, and infants or neonates who are treated for sepsis are likely higher but unknown at this time.

We require baseline observational data 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 this study will address.

Aims of the study

• Describe the microbiology, resistance patterns, antibiotic use patterns, and antimicrobial stewardship practices in hospitalised children treated for sepsis in Australia and New Zealand, including the burden of contaminated blood cultures in this population.
  
  
• Describe the management of hospitalised children treated for sepsis in Australia and New Zealand, including adherence to local guidelines and variation in care.
  
  
• Describe prevalence, resource utilisation, and outcomes in sub-groups of vulnerable children who are at high risk of being treated for sepsis, including those receiving cancer chemotherapy, and those identifying as Aboriginal, Torres Strait Islander, Pasifika or Māori ethnicity, those with chronic disease, and infants or neonates.
  
  
• Describe the admission and discharge diagnoses of hospitalised children treated for sepsis (in whom the admission and discharge diagnoses may differ).
  
  
• Describe the features of hospitalised children with discordant (non-septic) admission and discharge diagnoses.
  
  
• Identify features, including biomarkers and existing clinical scores, that identify hospitalised children treated for sepsis who are at risk of deterioration and poor outcomes.
  
  
• Identify the frequency and features of hospitalised children who deteriorate within 24 hours of admission and require treatment for sepsis in hospital wards.
  
  
• Identify feasible inclusion criteria and outcomes to be used in the design and conduct of future interventional sepsis trials.

Information for participants

Participant recruitment

1. All patients will be screened for eligibility in the Emergency Department. Sites with an electronic medical record (EMR) will screen for eligible patients within the first 24 hours of admission to hospital
2. When the patient is clinically stable, they will be enrolled into the study by the treating clinician or a member of the research team
3. Enrolment will include verbal consent and prospective data collection
4. Missed eligible patients will be identified by a review of the daily ED attendance record
5. Missed eligible patients will have data collected by retrospective chart review.

Recruitment process

Contact us for more information.

Inclusion criteria

1. Aged under 18 years; AND
2. Admission to hospital ward; AND
3. Treatment with intravenous (IV)/ intramuscular (IM)/ intraosseous (IO) antibiotics pre-hospital, in ED or within the first 24 hours of hospitalisation; AND
4. Circulatory support (fluid bolus or inotropic support) pre-hospital, in ED or within the first 24 hours of hospitalisation;

OR

• Admission diagnosis of sepsis or septic shock.

OR

• Admission to ICU or HDU within the first 24 hours of hospitalisation for treatment of severe infection.

Please note: Fluid bolus is defined as 5ml/kg or 500mls administered over 30 minutes. Inotropic support is defined as an intravenous infusion of inotrope/vasopressor.

Exclusion criteria

1. Patients who only receive antibiotics and circulatory support following induction of anaesthetic in the operating theatre
2. Patients not initially seen in the Emergency Department
3. Patients presenting with trauma who receive antibiotics for prophylaxis or circulatory support for blood loss.

Consent

As this is an observational non-interventional study, we will not seek written consent. The consent process will be divided into two sections:

• Waiver of consent for retrospective audit.
• Verbal consent for prospective data collection and three months follow up.

Parental verbal consent will be obtained for permission to get prospective data and permission to conduct follow up at three months, either by telephone call or email/text REDCap survey link to determine the outcome.

The parent/guardian will be provided with a study handout outlining the study. The treating clinician will seek consent at the time the participant meets eligibility criteria.

Research team

Research

SENTINEL Study: Methods

The SENTINEL study is a prospective observational study set in the following locations:

• Royal Children’s Hospital, Victoria, Australia
• Monash Health, Victoria, Australia
• Queensland Children’s Hospital, Queensland, Australia
• Gold Coast University Hospital, Queensland, Australia
• Sydney Children’s Hospital, New South Wales, Australia
• Westmead Children’s Hospital, New South Wales, Australia
• Women’s and Children’s Hospital, South Australia, Australia
• Perth Children’s Hospital, Western Australia, Australia
• Starship Hospital, Auckland, New Zealand
• Kidz First Children’s Hospital, Auckland, New Zealand
• Royal Darwin Hospital, Northern Territory, Australia
• Palmerston Hospital, Northern Territory, Australia

Contact us

SENTINEL Study
Murdoch Children's Research Institute
The Royal Children's Hospital
50 Flemington Road
Parkville VIC 3052
Australia

Email: [email protected]