What is PRoMPT BOLUS?
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 LR as they may be used in ordinary clinical care.
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.