Sepsis, Informed Consent, and the PRoMPT BOLUS Study

What is Sepsis?

Sepsis describes an extreme, life-threatening reaction to an infection. While fighting the infection, the body’s immune system triggers a chain reaction that leads to a rapid heart rate and low blood pressure. Each year in the United States, about 75,000 children require hospitalization for sepsis, most commonly in a pediatric intensive care unit (PICU). Sepsis accounts for 7% of all patients treated in PICUs and it is treated with intravenous (IV) fluids, antibiotics and other medications.

Doctors use two types of fluids to treat pediatric sepsis: normal saline and lactated Ringers. It is unknown which fluid is better. A large national study known as PRoMPT BOLUS seeks to discover if one of these fluids is safer and/or more effective than the other. Nationwide Children’s Hospital is one of many pediatric hospitals taking part in the study.

Exception from Informed Consent

Before enrolling a child in a research study, it is important families know the purpose of the study and the risks and benefits of participating in the project. In the case of PRoMPT BOLUS, children are randomly given one of the two IV fluids and then their progress is followed to see which fluid might be associated with better outcomes. However, these children have a life-threatening emergency, which means it may not be practical to obtain informed consent prior to the initiation of one of the two fluids.

Federal regulations allow for an exception to informed consent when the patient’s life is at risk, the best treatment is not known, the study might help the patient and it is not possible to get permission prior to study enrollment because immediate treatment is needed to save the child’s life. In these situations, informed consent is still required to remain in the study after the initial emergency is over.

PRoMPT BOLUS Study

This study seeks to enroll 8,000 children with sepsis in the United States, Canada, Australia and New Zealand. Children ages 6 months to 18 years suspected of having sepsis by their emergency medicine treatment team are eligible to participate in the study. Children are initially enrolled with an exception to informed consent and randomly selected to receive either normal saline OR lactated Ringers IV fluid during their first 48 hours in the hospital. Investigators then follow these patients through their hospital stay to see if there is a difference between the two groups who have received different fluids.

This study is important because pediatric sepsis is a relatively common life-threatening condition. Best outcomes in these patients depend on prompt treatment in the emergency department with the most effective fluid, antibiotics and other medications. And since the best choice of fluid in pediatric sepsis is unknown, the PRoMPT BOLUS study seeks to answer this question. In doing so, the study will have an impact on the health and wellbeing of children for generations to come.