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Your search keyword '"Elena Tsemberis"' showing total 3 results
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3 results on '"Elena Tsemberis"'

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

Author

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, and for the Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks

Subjects
Sepsis, Septic shock, Pediatric, Intravenous fluid, Crystalloid, Saline, Medicine (General), R5-920
Abstract

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 Australia/New Zealand starting on August 25, 2020, and continuing for 5 years. Children > 6 months to

Published
2021
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2. PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial

Author

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

Subjects
Comparative Effectiveness Research, Resuscitation, Medicine (General), Kidney Disease, medicine.medical_treatment, Medicine (miscellaneous), Crystalloid, Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, Cardiorespiratory Medicine and Haematology, 030204 cardiovascular system & hematology, Pragmatic trial, Study Protocol, 0302 clinical medicine, Bolus (medicine), Septic shock, Pharmacology (medical), 030212 general & internal medicine, Child, Randomized Controlled Trials as Topic, Pediatric, Saline, Shock, Hematology, Shock, Septic, 3. Good health, Infectious Diseases, 6.1 Pharmaceuticals, Shock (circulatory), Patient Safety, Saline Solution, medicine.symptom, medicine.medical_specialty, Renal failure, and PREDICT Networks, Clinical Trials and Supportive Activities, Clinical Sciences, Renal and urogenital, Sepsis, 03 medical and health sciences, R5-920, Clinical Research, General & Internal Medicine, medicine, PERC, Humans, Renal replacement therapy, Septic, business.industry, Evaluation of treatments and therapeutic interventions, Emergency department, Crystalloid Solutions, medicine.disease, Cardiovascular System & Hematology, Emergency medicine, Intravenous fluid, Fluid Therapy, business, Kidney disease
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 Australia/New Zealand starting on August 25, 2020, and continuing for 5 years. Children > 6 months to Discussion PRoMPT BOLUS will provide high-quality evidence for the comparative effectiveness of buffered/balanced crystalloids versus 0.9% saline for the initial fluid management of children with suspected septic shock in emergency settings. Trial registration PRoMPT BOLUS was first registered at ClinicalTrials.gov (NCT04102371) on September 25, 2019. Enrollment started on August 25, 2020.

Published
2021

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