PRoMPT BOLUS (PRagMatic Pediatric Trial of Balanced vs. nOrmaL Saline FlUid in Sepsis) is a clinical study 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 types of intravenous (IV) fluids. One fluid type is normal saline and the other is balanced fluids (such as lactated Ringer’s or PlasmaLyte). Both fluid types are effective to treat sepsis and both are commonly used, but we do not know if one of these fluid types is better.

All children who present to the Seattle Children’s Emergency Department with sepsis will be eligible to participate in this study. Sepsis is a severe inflammatory response to an infection that can cause low blood pressure and shock.

We will try to ask permission before a patient is enrolled in PRoMPT BOLUS. However, because patients with sepsis must be treated quickly, there may not be enough time to locate and talk to the patient’s parent or guardian about the study. In this case, patients may be enrolled in the study through a special process for clinical trials supported by the Food and Drug Administration (FDA) and Institutional Review Board called “Exception from Informed Consent.” Then, as soon as we can, the study team will inform the parent/guardian about the study and seek permission to continue in the study and to use their child’s data. So the ultimate choice to remain in the study will always be with the parent/guardian. If a parent/guardian prefers to not have their child be considered for this study in the event of sepsis, they can opt out here.

We are not aware of any reason at this time why anyone with sepsis would not choose to participate if awake and able to take part in decisions about their care. All patients enrolled in the study will receive one of the two commonly used IV fluids to treat sepsis along with the best locally available medical care available for their symptoms.

For more information, please go to https://www.research.chop.edu/prompt-bolus or contact Dr. Neil Uspal, (206) 987-9842 or promptbolus@seattlechildrens.org.