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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| Language: | English |
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BMC
2021-11-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05717-4 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-20T18:05:21Z |
| format | Article |
| id | doaj.art-7f4b0db0cbb04be2923d47d19bdc90f5 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-20T18:05:21Z |
| publishDate | 2021-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-7f4b0db0cbb04be2923d47d19bdc90f52022-12-21T19:30:34ZengBMCTrials1745-62152021-11-0122111410.1186/s13063-021-05717-4PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trialScott L. Weiss0Fran Balamuth1Elliot Long2Graham C. Thompson3Katie L. Hayes4Hannah Katcoff5Marlena Cook6Elena Tsemberis7Christopher P. Hickey8Amanda Williams9Sarah Williamson-Urquhart10Meredith L. Borland11Stuart R. Dalziel12Ben Gelbart13Stephen B. Freedman14Franz E. Babl15Jing Huang16Nathan Kuppermann17for the Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT NetworksDepartment of Anesthesiology and Critical Care, The Children’s Hospital of Philadelphia, Perelman School of Medicine at the University of PennsylvaniaThe Children’s Hospital of Philadelphia Pediatric Sepsis ProgramDepartment of Emergency Medicine, The Royal Children’s HospitalDepartments of Pediatrics and Emergency Medicine, Alberta Children’s Hospital Research Institute, Cumming School of Medicine, University of CalgaryThe Children’s Hospital of Philadelphia Pediatric Sepsis ProgramDepartment of Biomedical and Health Informatics, Data Science and Biostatistics Unit, The Children’s Hospital of PhiladelphiaDepartment of Pediatrics, The Children’s Hospital of Philadelphia, Perelman School of Medicine at the University of PennsylvaniaDepartment of Pediatrics, The Children’s Hospital of Philadelphia, Perelman School of Medicine at the University of PennsylvaniaThe Children’s Hospital of Philadelphia Pediatric Sepsis ProgramDepartment of Emergency Medicine, The Royal Children’s HospitalDepartments of Pediatrics and Emergency Medicine, Alberta Children’s Hospital Research Institute, Cumming School of Medicine, University of CalgaryDivisions of Emergency Medicine and Pediatrics, Perth Children’s Hospital, School of Medicine at the University of Western AustraliaDepartments of Surgery and Pediatrics: Child and Youth Health, Starship Children’s Hospital, University of AucklandDepartments of Pediatrics and Critical Care, The University of MelbourneSections of Pediatric Emergency Medicine and Gastroenterology, Departments of Pediatrics and Emergency Medicine, Cumming School of Medicine, University of CalgaryDepartment of Emergency Medicine, The Royal Children’s HospitalDepartment of Pediatrics, The Children’s Hospital of Philadelphia, Perelman School of Medicine at the University of PennsylvaniaDepartment of Emergency Medicine and Pediatrics, UC Davis School of medicine and UC Davis HealthAbstract 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.https://doi.org/10.1186/s13063-021-05717-4SepsisSeptic shockPediatricIntravenous fluidCrystalloidSaline |
| spellingShingle | 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 Trials Sepsis Septic shock Pediatric Intravenous fluid Crystalloid Saline |
| title | 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_short | 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 |
| topic | Sepsis Septic shock Pediatric Intravenous fluid Crystalloid Saline |
| url | https://doi.org/10.1186/s13063-021-05717-4 |
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