Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to determine which of two commonly used IV fluid types (normal saline (NS) versus balanced fluids (lactated ringer’s (LR) or PlasmaLyte) is most effective to treat children and teens with septic shock. Sepsis is a critical medical condition that can require rapid emergency treatment; national guidelines recommend treatment begin within 20 minutes of arrival to the emergency department.
PRoMPT BOLUS Study stands for “PRagMatic Pediatric Trial of Balanced vs. nOrmaL Saline FlUid in Sepsis.”
Who can participate?
Children and teens 6 months to 17 years old in the emergency room with suspected septic shock may be enrolled in this study.
What will happen in the study?
Because of the emergent nature of the condition and the need for rapid treatment, this study has been classified as an “Exception from Informed Consent” study, which allows us to conduct a research study in an emergency without first asking for consent. As soon as your child has stabilized, you will be informed of the study and will have the opportunity to withdraw.
If the ED doctor suspects that your child has septic shock, he/she will be enrolled and be randomly selected to receive one of two commonly used IV fluid types (NS vs LR or PlasmaLyte). All other tests and medications will be given according to normal routines in the hospital. Any fluid that your child needs will be given as study fluid during the first 24 hours in the hospital. Study team members will follow your child and other children and teens in the study to see which fluid worked the best.
You may choose to opt out of participation by visiting www.research.chop.edu/prompt-bolus/prompt-bolus-resources where you can sign up to receive a bracelet in the mail that your child may wear, or that you or another caregiver may hold for them. Also, your child’s name would appear on an opt-out list that clinicians consult prior to enrolling any child in the clinical trial. Again, it is important to note is that if your child is enrolled you may withdraw them from the study at any time.
What are the good things that can happen from this research?
Both IV fluid types are commonly used to treat sepsis and both are FDA-approved and effective in treating sepsis. However, right now we do not know if one fluid is better for treating sepsis, so we cannot know if it is better for your child to receive one or the other type of fluid.
Based on the information we get from this study, children who have sepsis in the future may benefit from what is learned during this study.
What are the bad things that can happen from this research?
Even though fluids can be life-saving, there are risks to receiving the study fluids. But the risks of the study fluids are similar to those that your child might have if he/she receives fluid treatment for their sepsis outside of this study.
Although all study patients will receive a fluid type that is effective, safe, and recommended for treatment of sepsis, the reason for this study is to determine which fluid may be the most effective and safest. Therefore, if there are differences in effectiveness and safety, hospital length of stay and other outcomes may be different between the two groups.
Will you/your child be paid to be in this research study?
There is no compensation for participation in this study.