Tags

Type your tag names separated by a space and hit enter

PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial.
Trials. 2021 Nov 06; 22(1):776.T

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.

Authors+Show Affiliations

Department of Anesthesiology and Critical Care, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. WeissS@chop.edu. The Children's Hospital of Philadelphia Pediatric Sepsis Program, Philadelphia, PA, USA. WeissS@chop.edu.The Children's Hospital of Philadelphia Pediatric Sepsis Program, Philadelphia, PA, USA. Department of Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.Department of Emergency Medicine, The Royal Children's Hospital, Parkville, Victoria, Australia. Departments of Pediatrics and Critical Care, The University of Melbourne, Parkville, Victoria, Australia. Murdoch Children's Research Institute, Melbourne, Victoria, Australia.Departments of Pediatrics and Emergency Medicine, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.The Children's Hospital of Philadelphia Pediatric Sepsis Program, Philadelphia, PA, USA.Department of Biomedical and Health Informatics, Data Science and Biostatistics Unit, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.Department of Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.Department of Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.The Children's Hospital of Philadelphia Pediatric Sepsis Program, Philadelphia, PA, USA.Department of Emergency Medicine, The Royal Children's Hospital, Parkville, Victoria, Australia.Departments of Pediatrics and Emergency Medicine, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.Divisions of Emergency Medicine and Pediatrics, Perth Children's Hospital, School of Medicine at the University of Western Australia, Crawley, Australia.Departments of Surgery and Pediatrics: Child and Youth Health, Starship Children's Hospital, University of Auckland, Auckland, New Zealand.Departments of Pediatrics and Critical Care, The University of Melbourne, Parkville, Victoria, Australia. Murdoch Children's Research Institute, Melbourne, Victoria, Australia. Australian and New Zealand Intensive Care Society Paediatric Study Group, Camberwell, Australia. Paediatric Intensive Care Unit, Royal Children's Hospital, Parkville, Victoria, Australia.Sections of Pediatric Emergency Medicine and Gastroenterology, Departments of Pediatrics and Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.Department of Emergency Medicine, The Royal Children's Hospital, Parkville, Victoria, Australia. Departments of Pediatrics and Critical Care, The University of Melbourne, Parkville, Victoria, Australia. Murdoch Children's Research Institute, Melbourne, Victoria, Australia.Department of Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.Department of Emergency Medicine and Pediatrics, UC Davis School of medicine and UC Davis Health, Sacramento, CA, USA.No affiliation info available

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

34742327

Citation

Weiss, Scott L., et al. "PRagMatic Pediatric Trial of Balanced Vs nOrmaL Saline FlUid in Sepsis: Study Protocol for the PRoMPT BOLUS Randomized Interventional Trial." Trials, vol. 22, no. 1, 2021, p. 776.
Weiss SL, Balamuth F, Long E, et al. PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial. Trials. 2021;22(1):776.
Weiss, S. L., Balamuth, F., Long, E., Thompson, G. C., Hayes, K. L., Katcoff, H., Cook, M., Tsemberis, E., Hickey, C. P., Williams, A., Williamson-Urquhart, S., Borland, M. L., Dalziel, S. R., Gelbart, B., Freedman, S. B., Babl, F. E., Huang, J., & Kuppermann, N. (2021). PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial. Trials, 22(1), 776. https://doi.org/10.1186/s13063-021-05717-4
Weiss SL, et al. PRagMatic Pediatric Trial of Balanced Vs nOrmaL Saline FlUid in Sepsis: Study Protocol for the PRoMPT BOLUS Randomized Interventional Trial. Trials. 2021 Nov 6;22(1):776. PubMed PMID: 34742327.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial. AU - Weiss,Scott L, AU - Balamuth,Fran, AU - Long,Elliot, AU - Thompson,Graham C, AU - Hayes,Katie L, AU - Katcoff,Hannah, AU - Cook,Marlena, AU - Tsemberis,Elena, AU - Hickey,Christopher P, AU - Williams,Amanda, AU - Williamson-Urquhart,Sarah, AU - Borland,Meredith L, AU - Dalziel,Stuart R, AU - Gelbart,Ben, AU - Freedman,Stephen B, AU - Babl,Franz E, AU - Huang,Jing, AU - Kuppermann,Nathan, AU - ,, Y1 - 2021/11/06/ PY - 2021/05/25/received PY - 2021/10/11/accepted PY - 2021/11/7/entrez PY - 2021/11/8/pubmed PY - 2021/11/10/medline KW - Crystalloid KW - Intravenous fluid KW - Pediatric KW - Pragmatic trial KW - Renal failure KW - Saline KW - Sepsis KW - Septic shock SP - 776 EP - 776 JF - Trials JO - Trials VL - 22 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/34742327/PRagMatic_Pediatric_Trial_of_Balanced_vs_nOrmaL_Saline_FlUid_in_Sepsis:_study_protocol_for_the_PRoMPT_BOLUS_randomized_interventional_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05717-4 DB - PRIME DP - Unbound Medicine ER -