PROMPT BOLUS Study
PROMPT BOLUS (PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis)
PROMPT BOLUS (PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis) is a clinical trial to compare two commonly used treatments for pediatric sepsis to see if one is more effective and safer than the other. The treatments in this study are two different intravenous (IV) fluids. One fluid is normal saline (NS) and the other is lactated Ringer's (LR).
Thousands of children die from septic shock each year worldwide. Most children admitted with sepsis receive initial resuscitation in an emergency department (ED), where septic shock remains one of the most critical of illnesses treated by ED clinicians. Sepsis is also the most expensive hospital condition, and the most common cause of pediatric multiple organ dysfunction syndrome (MODS). While all crystalloid fluids help to reverse shock, the most effective and safest type of crystalloid fluid resuscitation is unknown.
Crystalloid fluids can be categorised as non-buffered (most commonly 0.9% normal saline [NS]) or buffered/balanced fluids (BF). In the US where this trial originated, the most common BF is lactated Ringer's (LR), but other examples include Hartmann's solution and PlasmaLyte. NS and LR are inexpensive, stable at room temperature, and nearly universally available with identical storage volumes and dosing strategies. Notably, both are also of proven clinical benefit in septic shock and have extensive clinical experience for use in fluid resuscitation of critically ill patients. However, despite data suggesting that LR resuscitation may have superior efficacy and safety, NS remains the most commonly used fluid largely based on historical precedent.
To definitively test the comparative effectiveness of NS and LR, a well-powered randomised controlled trial (RCT) is necessary. A large pragmatic randomised trial embedded within everyday clinical practice provides a cost-efficient and generalisable approach to inform clinicians about best comparative effectiveness of common therapies. Data from a prior single-center feasibility study demonstrated that a pragmatic randomised clinical trial of NS versus LR for children with septic shock presenting to an emergency department is feasible and can be successfully carried out by embedding simple study procedures within routine clinical practice. These pilot data informed the current two-center Vanguard-phase study that will now test for differential clinical effects, as part of a definitive comparative effectiveness trial, of NS versus LR for crystalloid resuscitation of pediatric septic shock.
Our group, based at the Royal Children's Hospital in Melbourne, will be recruiting participating sites in Australia.
Principal Investigators (Australia)
Prof Franz Babl (Royal Children's Hospital; Murdoch Children's Research Institute, Centre for Integrated Critical Care, University of Melbourne)
Dr Elliot Long (Royal Children's Hospital; Murdoch Children's Research Institute, Centre for Integrated Critical Care, University of Melbourne)
PREDICT Network (Paediatric Research in Emergency Departments International Collaborative)
Royal Children's Hospital
Murdoch Children's Research Institute
Medical Research Future Fund ($3,000,000+)