Announcing a clinical trial for fluid resuscitation in suspected sepsis at Children’s Hospital Colorado
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. Sepsis is a severe inflammatory response to infection that can cause low blood pressure and shock, and the potential for chronic kidney injury and death.
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. For decades, the choice of a balanced crystalloid or normal saline fluid depended on doctor preference and available supplies. They are both used routinely every day for the treatment of sepsis in this country. In this trial, we hope to finally answer the question of whether one fluid really is best for kids, so we can help even more kids have better outcomes from sepsis.
“I have been studying sepsis and treating children with sepsis for my whole career. It’s a scary disease, but also one where we can really make a difference by getting kids the right care right away,” says Halden Scott, MD, a pediatric emergency physician at Children’s Colorado. “Yet, even though we know that giving IV fluids early is important to treating sepsis, we have never known which IV fluid worked best. That’s what makes this study so important.”
It is possible that any family could find themselves in an emergency situation and become eligible for this study. Families can tell us in advance that they would not want to participate in this study by opting out.
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, emergency physicians will briefly alert families to the opportunity to participate in this study. In the study, children will be randomized to either of the two effective liquids.
This special enrollment process is supported by the Food and Drug Administration (FDA) and Institutional Review Board and is called “Exception from Informed Consent.” 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.
At this time, we are not aware of any reason that someone with sepsis would not choose to participate in this study. All patients enrolled in the study will receive one of the two commonly used IV fluids to treat sepsis along with the best available, evidence-based medical care for their symptoms.
For more information
For more information on this nationwide study, please contact Lilliam Ambroggio, PhD, Associate Professor of Pediatrics-Emergency Medicine at University of Colorado School of Medicine, who is leading the study at Children’s Colorado at firstname.lastname@example.org.