PRagMatic Pediatric Trial of Balanced versus NOrmaL Saline FlUid in Sepsis (PRoMPT-BOLUS)

Every year, sepsis afflicts an estimated 4 million children annually1, and is estimated to be the most expensive hospital condition in the United States of America (US). It is also the most common cause of multiple organ dysfunction syndrome (MODS) and hospital death, resulting in the annual deaths of approximately 500 children in Australia and New Zealand (ANZ), 5,000 in the US, and thousands more worldwide5–7. Sepsis is recognised as an urgent global public health problem. The World Health Organisation and the US Centers for Disease Control and Prevention have called for optimized therapies8.

Unfortunately, the most effective and safest crystalloid fluid to use for initial resuscitation of septic shock has not yet been established.  Two types of crystalloids are used for resuscitation in sepsis: “Normal” Saline and Balanced Fluids e.g., Lactated Ringer’s or PlasmaLyte.  Balanced Fluids have well-established biologic and physiologic advantages over Normal Saline and prior studies have associated balanced fluids with reduced risk for MODS, acute kidney injury, immune dysfunction, coagulopathy, and death than Normal Saline in a variety of conditions. However, in the absence of paediatric-specific data, Normal Saline remains in overwhelming use worldwide for initial fluid resuscitation and is currently recommended by Paediatric Advanced Life Support (PALS), the organisation setting the standard for acute care in developed countries.

We will therefore undertake the PRoMPT-BOLUS study to test the relative effectiveness and safety of Balanced Fluids versus Normal Saline fluid resuscitation in children with suspected septic shock.

The aim of this study is to determine if fluid resuscitation with Balanced Fluid will improve clinical outcomes compared to fluid resuscitation with Normal Saline in paediatric septic shock. We will monitor the safety of Balanced Fluids versus Normal Saline in paediatric septic shock.

This is an international study lead by the PECARN network in the USA, that will also involve the Canadian PERC network and PREDICT.

Study design

Multicentre, non-blinded, randomised controlled trial.

Chief Investigators

Franz Babl, Ed Oakley, Stuart Dalziel, Meredith Borland, Elliot Long (ANZ), Scott Weiss, Fran Belamuth (Children’s Hospital of Philadelphia), Nate Kupperman (University of California, Davis)

Time frame

2020 – 2025

Funding

Medical Research Futures Fund (ANZ)
National Institutes of Health (USA)

Site locations

  • Royal Children’s Hospital, Melbourne (PI Elliot Long)
  • Starship Children’s Hospital, Auckland (PI Stuart Dalziel)
  • Perth Children’s Hospital, Perth (PI Meredith Borland)
  • Monash Children’s Hospital, Melbourne (PI Simon Craig)
  • Women’s and Children’s Hospital, Adelaide (PI Amit Kochar)
    (further 5 sites TBC)

Sample

PREDICT 2205, Total sites 8200, children aged > 6mths – <18 yrs.

Contact

Franz.babl@rch.org.au
Elliot.long@rch.org.au