Journal article

PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial

Scott L Weiss, Fran Balamuth, Elliot Long, Graham C Thompson, Katie L Hayes, Hannah Katcoff, Marlena Cook, Elena Tsemberis, Christopher P Hickey, Amanda Williams, Sarah Williamson-Urquhart, Meredith L Borland, Stuart R Dalziel, Ben Gelbart, Stephen B Freedman, Franz E Babl, Jing Huang, Nathan Kuppermann

TRIALS | BMC | Published : 2021

Abstract

BACKGROUND/AIMS: Despite evidence that preferential use of balanced/buffered fluids may improve outcomes compared with chloride-rich 0.9% saline, saline remains the most commonly used fluid for children with septic shock. We aim to determine if resuscitation with balanced/buffered fluids as part of usual care will improve outcomes, in part through reduced kidney injury and without an increase in adverse effects, compared to 0.9% saline for children with septic shock. METHODS: The Pragmatic Pediatric Trial of Balanced versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) study is an international, open-label pragmatic interventional trial being conducted at > 40 sites in the USA, Canada, and Au..

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Grants

Awarded by Eunice Kennedy Shriver National Institute of Child Health and Human Development


Awarded by Commonwealth of Pennsylvania Department of Health SAP


Awarded by Medical Research Futures Fund International Clinical Trial Collaboration


Awarded by Canadian Institutes of Health Research


Awarded by Emergency Medical Services for Children Network Development Demonstration Program of the Maternal and Child Health Bureau, Health Resources and Services Administration


Awarded by National Health and Medical Research Council (NHMRC), Canberra, Australia


Funding Acknowledgements

Funding is provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development R01HD101528, Commonwealth of Pennsylvania Department of Health SAP #4100085749, The Medical Research Futures Fund International Clinical Trial Collaboration (APP1190814), and the Canadian Institutes of Health Research 173498. Additional support is provided by The Children's Hospital of Philadelphia Research Institute and Alberta Children's Hospital Research Institute. The Pediatric Emergency Care Applied Research Network (PECARN) is funded through the Emergency Medical Services for Children Network Development Demonstration Program of the Maternal and Child Health Bureau, Health Resources and Services Administration, under cooperative agreement (awards U03MC00008, U03MC00001, U03MC00003, U03MC00006, U03MC00007, U03MC22684, and U03MC22685). The Pediatric Research in Emergency Departments International Collaborative (PREDICT) Network is funded, in part, through a National Health and Medical Research Council (NHMRC), Canberra, Australia, Centre of Research Excellence Grant (GNT1058560). SRD is partly funded by Cure Kids New Zealand. SF is supported by the Alberta Children's Hospital Foundation Professorship in Child Health and Wellness. FEB's time is part funded by an NHMRC Practitioner Fellowship and the Royal Children's Hospital Foundation, Melbourne, Australia. The content and conclusions of this article are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by, any funding or governmental agencies. The funding institutions had no role in (1) the conception, design, or conduct of the study; (2) the collection, management, analysis, interpretation, or presentation of the data; or (3) the preparation, review, or approval of the manuscript.