Sepsis Treatment Comparing Intravenous Solutions: The PRoMPT BOLUS Study – Phase III

Balanced Fluid Resuscitation to Decrease Kidney Injury in Children with Septic Shock

Protocol Description

The purpose of this multi-center research study is to determine if one type of intravenous (IV) fluid is better than another at protecting kidney function in treatment of pediatric patients with sepsis, a severe inflammatory response to an infection that can impair the normal function of certain organ systems. Both solutions used in this study are approved by the U.S. Food and Drug Administration and are recommended as part of standard care for sepsis, restoring fluid balance to improve blood pressure and lower heart rate.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, pediatric patients seen by the Emergency Department who will require hospitalization for their sepsis will be invited to participate in the research study.
Boys and Girls: Ages 6 months through 17 years


Participants will be randomly assigned to be given either normal saline or lactated Ringer’s solution for treatment of sepsis disease for up to 48 hours after the initial Emergency Department visit. After that time, if IV fluids are still required, the patient’s doctor will determine which IV fluid is used. For analytical purposes, researchers will use blood samples collected at the time of enrollment, after the study-fluid period is complete and before the patient leaves the hospital or 28 days after enrollment, whichever comes first.
Visits: 1, the initial Emergency Department visit
Duration: Up to 28 days

Status: Open to Enrollment

Primary Investigator

Robert Hickey, MD

Contact Information

For more information about the study or enrollment, please contact:
Dr. Hickey