Clinical Trials / Research Studies

Clinical Trials / Research Studies

What will happen in the study?

Because of the emergent nature of the condition and the need for rapid treatment, this study has been classified as an “Exception from Informed Consent” study, which allows us to conduct a research study in an emergency without first asking for consent. As soon as your child has stabilized, you will be informed of the study and will have the opportunity to withdraw.

If the ED doctor suspects that your child has septic shock, he/she will be enrolled and be randomly selected to receive one of two commonly used IV fluid types (NS vs LR or PlasmaLyte). All other tests and medications will be given according to normal routines in the hospital. Any fluid that your child needs will be given as study fluid during the first 24 hours in the hospital. Study team members will follow your child and other children and teens in the study to see which fluid worked the best.

You may choose to opt out of participation by visiting www.research.chop.edu/prompt-bolus/prompt-bolus-resources where you can sign up to receive a bracelet in the mail that your child may wear, or that you or another caregiver may hold for them. Also, your child’s name would appear on an opt-out list that clinicians consult prior to enrolling any child in the clinical trial. Again, it is important to note is that if your child is enrolled you may withdraw them from the study at any time.