Pragmatic Paediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS)
A pragmatic, international randomised controlled trial comparing 0.9% saline to balanced fluids for sepsis resuscitation and initial maintenance.
This study aims to:
To evaluate the effectiveness and safety of balanced fluids for sepsis resuscitation and initial maintenance compared to 0.9% saline.
Setting and target:
>10 PREDICT sites in Australia and New Zealand; 2200 patients; MRFF funded. 23 PECARN (US) sites; 4500 patients; NIH funded. 12 PERC (Can) sites; 2600 patients; CIHR funded.
Primary outcome:
Major Adverse Kidney Events (MAKE 30) at hospital discharge or within 30 days of enrolment (death, requirement for renal replacement therapy, persistent renal dysfunction).
Inclusion criteria:
Children aged 6 months – 18 years, requiring hospital admission for sepsis and >1 fluid bolus.
Exclusion criteria:
40ml/kg fluid, clinician judgement not safe (suspected brain herniation, known hyperkalaemia / hypercalcaemia / hepatic or renal failure, known metabolic or mitochondrial disease, known pregnancy, known fluid allergy.
Ethics and consent:
Ethics approval for delayed consent (waiver of consent to randomise). Consent by the research team once patient stabilised.
Status:
PROMPT Bolus will begin recruitment at RCH in March 2021, study duration 4.5 years. Enrolment in the US started in August 2020. Enrolment in Canada has not yet started.
Australian and New Zealand sites:
- Kidz First Hospital, Middlemore (NZ)
- Waikato Hospital (NZ)
- Starship Hospital (NZ)
- Royal Darwin Hospital (NT)
- Gold Coast University Hospital (QLD)
- Queensland Children’s Hospital (QLD)
- Westmead Children’s Hospital (NSW)
- Sydney Children’s Hospital (NSW)
- Perth Children’s Hospital, Perth (WA)
- Monash Health
- Women’s and Children’s Hospital, Adelaide (SA)
- The Royal Children’s Hospital (VIC)
- Townsville Hospital (QLD)