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

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

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...

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Autores principales: 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, for the Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks
Formato: article
Lenguaje:EN
Publicado: BMC 2021
Materias:
Sepsis
Septic shock
Pediatric
Intravenous fluid
Crystalloid
Saline
Medicine (General)
R5-920
Acceso en línea:https://doaj.org/article/7f4b0db0cbb04be2923d47d19bdc90f5
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spelling oai:doaj.org-article:7f4b0db0cbb04be2923d47d19bdc90f52021-11-08T11:03:10ZPRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial10.1186/s13063-021-05717-41745-6215https://doaj.org/article/7f4b0db0cbb04be2923d47d19bdc90f52021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05717-4https://doaj.org/toc/1745-6215Abstract 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 < 18 years treated for suspected septic shock with abnormal perfusion in an emergency department will be randomized to receive either balanced/buffered crystalloids (intervention) or 0.9% saline (control) for initial resuscitation and maintenance fluids for up to 48 h. Eligible patients are enrolled and randomized using serially numbered, opaque envelopes concurrent with clinical care. Given the life-threatening nature of septic shock and narrow therapeutic window to start fluid resuscitation, patients may be enrolled under “exception from informed consent” in the USA or “deferred consent” in Canada and Australia/New Zealand. Other than fluid type, all decisions about timing, volume, and rate of fluid administration remain at the discretion of the treating clinicians. For pragmatic reasons, clinicians will not be blinded to study fluid type. Anticipated enrollment is 8800 patients. The primary outcome will be major adverse kidney events within 30 days (MAKE30), a composite of death, renal replacement therapy, and persistent kidney dysfunction. Additional effectiveness, safety, and biologic outcomes will also be analyzed. 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.Scott L. WeissFran BalamuthElliot LongGraham C. ThompsonKatie L. HayesHannah KatcoffMarlena CookElena TsemberisChristopher P. HickeyAmanda WilliamsSarah Williamson-UrquhartMeredith L. BorlandStuart R. DalzielBen GelbartStephen B. FreedmanFranz E. BablJing HuangNathan Kuppermannfor the Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT NetworksBMCarticleSepsisSeptic shockPediatricIntravenous fluidCrystalloidSalineMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-14 (2021)
institution DOAJ
collection DOAJ
language EN
topic Sepsis
Septic shock
Pediatric
Intravenous fluid
Crystalloid
Saline
Medicine (General)
R5-920
spellingShingle Sepsis
Septic shock
Pediatric
Intravenous fluid
Crystalloid
Saline
Medicine (General)
R5-920
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
for the Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks
PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial
description 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 < 18 years treated for suspected septic shock with abnormal perfusion in an emergency department will be randomized to receive either balanced/buffered crystalloids (intervention) or 0.9% saline (control) for initial resuscitation and maintenance fluids for up to 48 h. Eligible patients are enrolled and randomized using serially numbered, opaque envelopes concurrent with clinical care. Given the life-threatening nature of septic shock and narrow therapeutic window to start fluid resuscitation, patients may be enrolled under “exception from informed consent” in the USA or “deferred consent” in Canada and Australia/New Zealand. Other than fluid type, all decisions about timing, volume, and rate of fluid administration remain at the discretion of the treating clinicians. For pragmatic reasons, clinicians will not be blinded to study fluid type. Anticipated enrollment is 8800 patients. The primary outcome will be major adverse kidney events within 30 days (MAKE30), a composite of death, renal replacement therapy, and persistent kidney dysfunction. Additional effectiveness, safety, and biologic outcomes will also be analyzed. 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.
format article
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
for the Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks
author_facet 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
for the Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks
author_sort Scott L. Weiss
title PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial
title_short PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial
title_full PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial
title_fullStr PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial
title_full_unstemmed PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial
title_sort pragmatic pediatric trial of balanced vs normal saline fluid in sepsis: study protocol for the prompt bolus randomized interventional trial
publisher BMC
publishDate 2021
url https://doaj.org/article/7f4b0db0cbb04be2923d47d19bdc90f5
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