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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, Aukland, New Zealand
  • Kidz First Children’s Hospital, Auckland, New Zealand
  • Royal Darwin Hospital, Northern Territory, Australia
  • Palmerston Hospital, Northern Territory, Australia

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. Enrollment 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:

participant-recruitment-workflow

Inclusion criteria:

  1. Aged <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 first 24 hours of hospitalisation; AND
  4. Circulatory support (fluid bolus or inotropic support) pre-hospital, in ED or within first 24 hours of hospitalisation;

OR

Admission diagnosis of sepsis or septic shock

OR

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

Note:
Fluid bolus defined as 5ml/kg or 500mls administered over 30 minutes.

Inotropic support 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 (i.e transferred to ward or admitted via clinic);
  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, written consent will not be sought.

The consent process will be divided into two sections:

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

Parental verbal consent will be obtained for permission to obtain 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. Consent will be sought by the treating clinician at the time the participant meets eligibility criteria.