Speakers
Scott L. Weiss, MD, MSCE
Division Chief, Critical Care Medicine
Vice-Chair of Research, Department of Pediatrics
Nemours Children’s Hospital, Delaware
Professor of Pediatrics and Pathology & Genomic Medicine
Sidney Kimmel Medical College at Thomas Jefferson University
Fran Balamuth, MD, PhD, MSCE
Division Chief, Emergency Medicine
Co-Director, CHOP Pediatric Sepsis Program
Children’s Hospital of Philadelphia
Professor of Pediatrics
University of Pennsylvania Perelman School of Medicine
Keywords
Sepsis; Fluids: Balanced Crytalloids; Saline; Pediatrics; Emergency Medicine
Key Points
- There are approximately 18,000 cases of pediatric sepsis and 1,800 attributable deaths annually in the U.S. Studies in adults have suggested that treatment with balanced fluids instead of normal saline might reduce major adverse kidney events, but subsequent larger studies and meta-analyses failed to show a definitive benefit.
- PRoMPT BOLUS is an international, large, pragmatic randomized clinical trial that sought to compare the effect of balanced fluids and 0.9% saline on a composite endpoint in pediatric emergency department patients with suspected septic shock. MAKE30, the composite endpoint, includes death, new renal replacement therapy, and persistent kidney dysfunction. The trial was designed to evaluate effectiveness under usual clinical conditions rather than efficacy in a strictly controlled environment.
- Th research team found no significant difference in the primary outcome between the balanced fluid arm and the saline arm. Balanced fluid did mitigate hyperchloremia, but this did not translate into differences in patient-centered clinical outcomes. Both crystalloid fluid types were safe and effective. Clinicians should use the most efficient, cost-effective fluid with consideration for balanced fluid if biochemical changes are problematic.
Discussion Themes
The complexities of running an international trial include merging databases from different countries and navigating varied regulatory requirements for deferred and exception-based consent.
The discussion explored whether different statistical approaches might have revealed subtle differences not captured by the trial’s primary analysis.