1. PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial
- Author
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Weiss, Scott L, Balamuth, Fran, Long, Elliot, Thompson, Graham C, Hayes, Katie L, Katcoff, Hannah, Cook, Marlena, Tsemberis, Elena, Hickey, Christopher P, Williams, Amanda, Williamson-Urquhart, Sarah, Borland, Meredith L, Dalziel, Stuart R, Gelbart, Ben, Freedman, Stephen B, Babl, Franz E, Huang, Jing, and Kuppermann, Nathan
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Health Sciences ,Kidney Disease ,Pediatric ,Infectious Diseases ,Sepsis ,Hematology ,Patient Safety ,Clinical Trials and Supportive Activities ,Comparative Effectiveness Research ,Clinical Research ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Renal and urogenital ,Child ,Crystalloid Solutions ,Fluid Therapy ,Humans ,Randomized Controlled Trials as Topic ,Saline Solution ,Shock ,Septic ,Septic shock ,Intravenous fluid ,Crystalloid ,Saline ,Renal failure ,Pragmatic trial ,Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN ,PERC ,and PREDICT Networks ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology ,General & Internal Medicine ,Clinical sciences ,Epidemiology ,Health services and systems - Abstract
Background/aimsDespite 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.MethodsThe 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 Australia/New Zealand starting on August 25, 2020, and continuing for 5 years. Children > 6 months to
- Published
- 2021