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Frequently Asked Questions | Overview

How will the study work?

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 balanced IV fluids as part of their sepsis treatment. At Boston Children’s, patients who are randomized to balanced fluids will be treated with lactated Ringer’s (LR), but at other study sites they may receive Plasma-Lyte. They will then receive study fluid as their treatment fluid during the remainder 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.

What is the difference between NS and LR?

Both NS and LR are electrolyte solutions — forms of salt water — that are safe, FDA-approved, and commonly used to treat sepsis. At Boston Children’s Hospital, patients with sepsis are commonly treated with both NS and LR in the emergency department and intensive care units, depending on the preferences of the doctors taking care of them. 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.

Why is this study being done?

Although both NS and balanced fluids 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 in Pediatric Intensive Care Units (PICU). However, nobody yet knows for sure which fluid is safer or more effective.

What are the risks of study participation?

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 the hospital or other outcomes may be different depending on the fluid you receive, and one fluid may have higher mortality than the other.

Will the study affect any other part of a child’s treatment for sepsis?

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.

What if my child is enrolled in the study and I change my mind about wanting them to participate?

A subject is free to withdraw from study participation at any time by contacting the study team either in person or by email at PROMPTBolus@childrens.harvard.edu. If you choose to withdraw, you may also ask that we not include any data collected up to that point in our study analysis. Please note that by law we will still be required to report this data to the Food and Drug Administration, which determines whether medications such as LR and NS are safe and effective.

What if I have questions/concerns about EFIC?

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.

What if I do not want my child to participate in the study at all?

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 are present at any study site.

How is PRoMPT BOLUS different from other clinical trials?

Most clinical trials outline very strict eligibility criteria for enrollment and provide an extensive protocol of therapy for subjects in the study. However, PRoMPT BOLUS is a pragmatic clinical trial, which means that the study conditions mimic “real life” as much as possible with simple inclusion criteria, few exclusion criteria, and very few elements of care that are protocolized. Our goal is to compare NS and balanced fluids as they may be used in ordinary clinical care.

Exception from Informed Consent (EFIC)

Ethical standards required that researchers get permission before a person can be included in a study through a process termed prospective informed consent. When time permits and it is safe to do so, we will ask permission before a person is enrolled into PRoMPT BOLUS. However, we realize that most people suffering from sepsis will be too sick to give consent and, since sepsis must be treated quickly, there may not be enough time to locate and talk to the person’s parent, guardian, or legal representative about the study. We anticipate that most patients will need be enrolled in the study without his/her legal representative’s consent. This is called “Exception from Informed Consent” (EFIC). Once the representative is located or the patient improves, they will be told about the study and asked for permission to continue in the study.