Eunice Kennedy Shriver National Institute of Child Health and Human Development 3R01HD101528-05S1

PROMPT BOLUS admin supplement

A funded study to compare normal saline and balanced fluids in pediatric septic shock to improve clinical outcomes and safety.

Description

This study aims to compare the effectiveness of two common types of crystalloid fluids—normal saline (NS) and balanced fluids (BF)—in improving clinical outcomes in children with septic shock. The study is a large, pragmatic, randomized, open-label trial involving 18 pediatric emergency departments across the US, Canada, Australia, and New Zealand. It plans to enroll 8,800 children with suspected septic shock. Patients will be randomized to receive either NS or BF for 24-48 hours, with other aspects of care at the discretion of the care team. The primary outcome is the incidence of major adverse kidney events within 30 days (MAKE30), including persistent kidney dysfunction, dialysis initiation, or death. Secondary outcomes include individual components of MAKE30, hospital-free days, length of stay, 90-day mortality, and safety events. This trial aims to provide definitive evidence to shift clinical practice from saline to balanced fluid resuscitation in pediatric septic shock.

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