ANZICS PSG Endorsed Study

PROMPT BOLUS Study

PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis Study

Study Description

The PROMPT BOLUS Study is an open label clinical trial to compare two crystalliod fluids for pediatric sepsis to see if one is more effective and safer than the other.

The safest crystalloid fluid to use for initial resuscitation of septic shock has not yet been established. Two types of crystalloids are suitable for use: 0.9% (normal) saline and balanced fluids (Hartmann’s Solution, Lactated Ringer’s, and PlasmaLyte). Though the overwhelming majority of clinicians in EDs use 0.9% saline as a resuscitation fluid in practice, balanced fluids have potential biologic and physiologic advantages. With electrolyte composition similar to human plasma, balanced fluids may reduce the risk of hyperchloraemia and acidosis as contributors to acute kidney injury when compared to 0.9% saline.

The PROMPT BOLUS study will compare normal saline (NS) and balanced fluids for both acute resuscitation and as maintenance fluids for up to 48 hours after hospitalisation. Pragmatically, the
study allows all further management to be at the discretion of the treating team. The primary outcome will be the incidence of Major Adverse Kidney Events within 30 days of randomization
(MAKE30: death, renal replacement therapy, persistent kidney dysfunction) in each treatment group. We hypothesize that septic children treated with balanced fluids will have fewer MAKE30
events compared to those treated with 0.9% saline.

This study was initiated by a team from the PECARN collaboration (Pediatric Emergency Care Applied Research Network) in the United States led by Scott Weiss and Fran Balamuth from the Children’s Hospital of Philadelphia (CHOP) and Nate Kuppermann from the University of California Davis in a collaboration of emergency and intensive care services. A feasability pilot has been completed at CHOP.

Reference

PSG1920-02

Contact

ANZICS Office