Prompt Bolus Trial Research | Overview
PRagMatic Pediatric Trial of Balanced vs. nOrmaL Saline FlUid in Sepsis (PRoMPT BOLUS) 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 fluids: normal saline and balanced fluids (including lactated Ringer's (LR) or Plasma-Lyte (PL)). Patients at Boston Children’s will receive either normal saline or lactated Ringer’s.
What is sepsis?
Sepsis is a potentially life threatening response to infection that:
- affects more than 70,000 children in the United States every year
- can happen to someone of any age
- can cause damage to many of the body’s organs
- can prevent a person from being able to function normally or independently
- can limit awareness and cause coma
- can cause death
How is sepsis treated?
Sepsis is treated with emergency therapies that include antibiotics and fluids, usually given through an IV. The most common place for sepsis to be treated when it occurs in the community is in an emergency department (ED).
What is PRoMPT BOLUS?
PRoMPT BOLUS is a clinical trial to compare two IV fluid treatments for pediatric sepsis. One fluid type is 0.9 percent normal saline (NS), and the other is balanced fluids (including lactated Ringer’s [LR] or Plasma-Lyte [PL]). At Boston Children’s, study participants will either receive NS or LR. Both fluid types are commonly used and both are helpful to treat pediatric sepsis, but we do not yet know which fluid type 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 only determines what kind of fluid the patient receives — not any other care.
PRoMPT BOLUS began as a pilot version at Children’s Hospital of Philadelphia (CHOP) that helped the hospital to improve the design of the study in the best possible way. The next phase is a multicenter clinical trial involving more than 20 U.S. sites through the Pediatric Emergency Care Applied Research Network (PECARN), as well as study sites in Canada, Australia, and New Zealand. Across all sites, PRoMPT BOLUS will ultimately enroll more than 8,000 children with sepsis.