PROMPT BOLUS Study

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

Sepsis is one of the most common causes of multiple organ dysfunction and death in children and is recognised as an urgent global public health problem.

One of the key research questions is the optimal type of fluid to use in paediatric sepsis. We know that all crystalloid fluids help to reverse shock and children admitted with suspected sepsis routinely receive fluid resuscitation in the emergency department, on wards and in the intensive care unit.

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 over Normal Saline in a variety of settings and conditions. However, in the absence of paediatric-specific data, Normal Saline remains in overwhelming use worldwide for initial fluid resuscitation in paediatric sepsis and is currently recommended by Advanced Paediatric Life Support Life Support (APLS), the organisation setting the standard for acute care in Australia and New Zealand and elsewhere.

PROMPT BOLUS (PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis) is a large pragmatic randomised trial comparing Normal Saline and Balanced Fluids e.g. Lactated Ringer’s or PlasmaLyte in children with suspected sepsis. The trial is embedded within everyday clinical practice and provides a cost-efficient and generalisable method of informing best practice.

This is an international study led by the PECARN network in the United States that also involves the Australian & New Zealand PREDICT network.

The study has been endorsed by the Australian College of Emergency Medicine Clinical Trials Network (AC EMCTN0005) and the Australian and New Zealand Intensive Care Society Paediatric Study Group (PSG1920-02).

Study design

Multicentre, non-blinded, randomised controlled trial.

Chief Investigators

Principal investigators United States
Prof Fran Balamuth (Children’s Hospital of Philadelphia)
Prof Scott Weiss (Children’s Hospital of Philadelphia)
Prof Nate Kuppermann (UC Davis Children’s Hospital)

Principal investigators Australia and New Zealand
Dr Elliot Long (Royal Children’s Hospital)
Prof Franz Babl (Royal Children’s Hospital; Murdoch Children’s Research Institute; Centre for Integrated Critical Care, University of Melbourne)
Prof Ed Oakley (Royal Children’s Hospital)
Prof Meredith Borland (Perth Children’s Hospital)
Prof Stuart Dalziel (Starship Children’s Hospital, Auckland)
Prof Andreas Schibler (Queensland Children’s Hospital)
Dr Ben Gelbart (Royal Children’s Hospital)
Dr Sarah McNab (Royal Children’s Hospital)

Timeframe

2020 – 2025

Funding

Medical Research Futures Fund (ANZ $3,000,000)
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)
  • Gold Coast University Hospital (PI Shane George)
  • Queensland Children’s Hospital (PI Natalie Phillips)
  • Children’s Hospital at Westmead (PI Shefali Jani)
  • Sydney Children’s Hospital, Randwick (PI Arjun Rao)
  • Kidz First Hospital, Middlemore, (PI Eunicia Tan)
  • The Royal Darwin Hospital, (PI Anna Lithgow)

Sample

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

Clinical Trial Registration

ClinicalTrials.gov :Identifier: NCT04102371

Contact

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

View entry on MCRI Projects page.