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About PRoMPT BOLUS
The goal of PRoMPT BOLUS is to compare normal saline (NS) and lactated Ringer’s (LR) as they may be used in ordinary clinical care. Both fluids are commonly used, and both are helpful to treat pediatric 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 protocolized.
PRoMPT BOLUS began as pilot version at CHOP that helped to improve the design of the study in the best possible way. The study will enter into a Pennsylvania Vanguard Phase during which CHOP and UPMC Children’s Hospital of Pittsburgh will enroll patients. PRoMPT BOLUS will ultimately be a large clinical trial that will enroll over 8,000 children with sepsis across the United States, Canada, Australia, and New Zealand.
Study Population
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.