PROMPT BOLUS (PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis) is a clinical trial 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 intravenous (IV) fluid types. One fluid type is 0.9% “normal” saline (NS) and the other is balanced fluids (including lactated Ringer’s [LR] or Plasma-Lyte [PL]).
To “opt-out” of the PRoMPT BOLUS clinical trial, click here.
What is Sepsis?
Sepsis is a potentially life threatening response to infection that
Affects over 70,000 children in the United States every year
Can happen to someone of any age
Can cause damage to many of the body’s organs
Can prevent a person from being able to function normally or independently
Can limit awareness and cause coma
Can cause death
How is Sepsis Treated?
Sepsis is treated with emergency therapies that include antibiotics and fluids, usually given through an IV. The most common place for sepsis to be treated when it occurs in the community is in an emergency department (ED).
What is PRoMPT BOLUS?
PRoMPT BOLUS is a clinical trial to compare two IV fluid treatments for pediatric sepsis. One fluid type is 0.9% normal saline (NS) and the other is balanced fluids (including lactated Ringer’s [LR] or Plasma-Lyte [PL]). Both fluid types are commonly used and both are helpful to treat pediatric sepsis but we do not yet know which fluid type is the safest and most effective.
PRoMPT BOLUS began as pilot version at CHOP that helped us to improve the design of the study in the best possible way. The next phase is a multicenter clinical trial involving over 20 US sites through the Pediatric Emergency Care Applied Research Network (PECARN), as well as study sites in Canada, Australia, and New Zealand. Across all sites, PRoMPT BOLUS will ultimately enroll over 8,000 children with sepsis.
PRoMPT BOLUS will enroll children over 6 months and less than 18 years of age with possible sepsis during a emergency department visit. Children will be considered to have possible sepsis if their doctor thinks they may have sepsis that will require treatment with both IV antibiotics and IV fluids and their doctor is worried about possible shock. The study will include children who are previously healthy, as well as children with chronic medical problems.
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
What is Exception From Informed Consent (EFIC)?
The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research protection involving medicines. The FDA has created a set of special rules, called “Exception From Informed Consent” (EFIC), for clinical trials that apply to critically ill patients who require emergent therapy when prospective informed consent is not possible or may put the patient at risk for increased harm by delaying potentially life-saving therapies. Under some circumstances, there may not be time to seek prospective informed consent from every eligible patient and, in some cases, discussing a possible option to enroll in a study may itself cause dangerous delays in a person’s care. Nonetheless, many critically ill patients could benefit from enrollment into an appropriate clinical trial. Therefore, to ensure that clinical trials can be conducted for patients in emergency situations, the FDA established rules for EFIC that require special safeguards to ensure that most people would consider the study to be ethical and appropriate. These special rules allow research studies in certain emergency situations to be conducted without prospective informed consent.
EFIC can only be used when:
The person’s life is at risk, AND,
The best treatment is not known, AND
The study might help the person, AND
It is not possible to get permission:
from the person because of his or her medical condition nor
from the person’s guardian because there is a very short amount of time required to treat the medical problem
Before researchers can start a study using EFIC, they must provide information about the study to the community and get their feedback. We have conducted surveys and performed focus groups with Lurie Children’s families. If you would like to fill out a short online survey, please click here.