PRagMatic paediatric trial of balanced vs normal saline fluid in sepsis
This study is now recruiting
About PRoMPT BOLUS
The goal of PRoMPT BOLUS is to compare 0.9% saline and balanced fluids that are currently both used in routine clinical care. Both fluids are commonly used, and both are helpful to treat paediatric sepsis, but we do not yet know which fluid is the safest and most effective. PRoMPT BOLUS is a pragmatic clinical trial, which means that the study conditions mimic “real life” as much as possible with simple inclusion criteria, few exclusion criteria, and very few elements of care that are protocolised. PRoMPT BOLUS is a large clinical trial that will enroll over 8,000 children with sepsis across the United States, Canada, Australia, and New Zealand.
PRoMPT BOLUS will enroll children over 6 months and less than 18 years of age with possible sepsis during an emergency department visit at a study site. Children will be considered to have possible sepsis if their doctor thinks they may have sepsis that will require treatment with both IV antibiotics and IV fluids, and their doctor is worried about possible shock. The study will include children who are previously healthy, as well as children with chronic medical problems.
Principal Investigator: A/Prof Elliot Long
Research Coordinator: Amanda Williams
Australian and New Zealand Steering Committee: Catherine Wilson, Dr Meredith Borland, Dr Sarah McNab, Dr Ben Gelbart, Prof Ed Oakley, Prof Franz Babl, Prof Stuart Dalziel