If a child is enrolled in PRoMPT BOLUS, they will be randomly assigned during their ED visit (like the flip of a coin) to receive either NS or LR IV fluids as part of their sepsis treatment. They will then receive study fluid as their treatment fluid during the remained of their ED visit and for up to 48 hours of their hospitalization if they are admitted to the hospital. The child’s doctors will determine when to give fluid and how much fluid to give, just as they would for a child not in the study.
Both NS and LR are electrolyte solutions- forms of salt water- that are safe, FDA-approved, and commonly used to treat sepsis. At CHOP, about half of children admitted to the Pediatric Intensive Care Unit (PICU) are treated with NS and half are treated with LR. The chemical composition of NS and LR are slightly different in that NS has only sodium and chloride, while LR contains less sodium, less chloride, and also has small amounts of other electrolytes like calcium and potassium.
Although both NS and LR are safe, FDA-approved, and commonly used to treat sepsis, nobody knows for sure whether one fluid is more effective and safer to treat sepsis than the other. Several prior studies have suggested that LR may be superior to NS, but a clear determination cannot be made without a large clinical trial. In pediatrics, NS is generally the preferred fluid used to treat sepsis but LR is also commonly used, especially for children admitted to the CHOP Pediatric Intensive Care Unit (PICU). However, nobody yet knows for sure which fluid is safer or more effective.
Because both fluid types are effective, safe, and recommended for treatment of sepsis, all children in this study will receive standard care, regardless of which fluid is given. But because, as part of this study, you will be randomly assigned (like a “flip of a coin”) to receive either NS or LR rather than your doctor selecting which fluid to give you, you may receive a fluid that you might not have otherwise received. If there are differences in effectiveness and safety between these two fluids, then length of stay in hospital or other outcomes may be different depending on the fluid you receive and one fluid may have higher mortality than the other.
NO. Decisions about when and how much fluid a child receives, as well as any other medications that they might need will not be affected by the study. These will be decided by the treatment team as they normally would for any child with possible sepsis.
A subject is free to withdraw from study participation at any time by contacting the study team either in person or by email: PRoMPT_BOLUS@email.chop.edu
We encourage you to contact us with any questions/concerns and/or complete an online survey, so that we may work together to share information about patient enrollment through EFIC and learn from each other.
If you would like to opt your child out of the study so that they would not be included if they developed possible sepsis, please fill out this form. Any patient who has opted out will be mailed a bracelet that they must wear for the duration of the study so that they will not be enrolled even if they present to the CHOP or UPMC Children’s Hospital of Pittsburgh Emergency Department with possible sepsis.