Pragmatic Pediatric Trial of Balanced Versus Normal Saline (NS) Fluid in Sepsis (PRoMPT BOLUS)

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Summary

In this pragmatic randomized comparative effectiveness trial that will enroll 8,930 children with suspected septic shock across PECARN hospitals, and will test the hypothesis that resuscitation with lactated Ringer’s (LR) improves hospital mortality, reduces kidney injury, and lowers length of stay compared to resuscitation with normal saline (NS). Sepsis is a leading cause of morbidity and mortality in children, for which crystalloid fluid resuscitation is a critical treatment. Although increasing data supports better efficacy and safety for LR than 0.9% NS, most children are resuscitated with NS and definitive data for the best fluid selection are lacking.

Key Publications

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Study Details

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PECARN Node

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Health Impact Summary

This study will definitively answer which crystalloid fluid is best for resuscitation of children with septic shock. If LR has demonstrably superior efficacy, a relatively cost-neutral paradigm shift to LR-based resuscitation could save hundreds of children's lives every year in the US and thousands more worldwide.

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Study Related External Media and Publications

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