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FLUID trial: a protocol for a hospital-wide open-label cluster crossover pragmatic comparative effectiveness randomised pilot trial
  1. Lauralyn McIntyre1,2,3,
  2. Monica Taljaard1,3,
  3. Tracy McArdle1,
  4. Alison Fox-Robichaud4,
  5. Shane W English1,2,
  6. Claudio Martin5,
  7. John Marshall6,
  8. Kusum Menon7,
  9. John Muscedere8,
  10. Deborah J Cook9,
  11. Charles Weijer10,
  12. Raphael Saginur11,
  13. Alies Maybee12,
  14. Akshai Iyengar13,
  15. Alan Forster1,
  16. Ian D Graham1,
  17. Steven Hawken1,3,
  18. Colin McCartney14,
  19. Andrew JE Seely1,15,
  20. Ian G Stiell1,
  21. Kednapa Thavorn1,3,
  22. Dean A Fergusson1,3
  1. 1 Department of Epidemiology, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  2. 2 Department of Medicine, Division of Critical Care, University of Ottawa, Ottawa, Ontario, Canada
  3. 3 School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada
  4. 4 Department of Medicine, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada
  5. 5 Division of Critical Care Medicine, London Health Sciences Centre, Western University, London, Ontario, Canada
  6. 6 Department of Surgery, St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
  7. 7 Children’s Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada
  8. 8 Department of Critical Care Medicine, Kingston General Hospital, Queen’s University, Kingston, Ontario, Canada
  9. 9 Departments of Medicine, Clinical Epidemiology and Biostatistics, St Joseph’s Healthcare Hamilton, McMaster University, Hamilton, Ontario, Canada
  10. 10 Rotman Institute of Philosophy, Western University, London, Ontario, Canada
  11. 11 Department of Medicine, The Ottawa Hospital (Infectious Diseases), University of Ottawa, Ottawa, Ontario, Canada
  12. 12 Patient Engagement Advisory Board, Bruyère Research Institute, Ottawa, Ontario, Canada
  13. 13 The Queensway Carleton Hospital, Ottawa, Ontario, Canada
  14. 14 Department of Anesthesiology, The Ottawa Hospital, Ottawa, Ontario, Canada
  15. 15 Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada
  1. Correspondence to Dr Lauralyn McIntyre; lmcintyre{at}ohri.ca

Abstract

Introduction 0.9% saline and Ringer’s lactate are the two most common resuscitation crystalloid fluids. 0.9% saline may lead to hyperchloraemic metabolic acidosis and may be associated with impaired kidney function and death. Few large multicentre randomised trials have been conducted to evaluate the effect of these two fluids on clinically important outcomes.

Methods FLUID is a pragmatic pilot cluster randomised crossover trial in which four hospitals will be randomised to normal saline or Ringer’s lactate for 14 weeks, then crossover to the alternative fluid for the subsequent 14 weeks after 1 to 3 week transition. With waiver of informed consent, all adult and paediatric patients admitted to participating sites will be included in the FLUID trial except for neonates. Primary feasibility outcome is study fluid protocol adherence (target:≥80%). Secondary feasibility outcomes include time to research ethics board (REB) approval and readiness to trial initiation (≤3 months from REB submission and approval). Primary (composite of death or re-admission to hospital in first 90 days of index hospitalisation) and secondary clinical outcomes for the future large FLUID trial will be described. Protocol adherence will be collected by site at specified time points. All clinical data will be obtained at patient level through provincial health administrative data held at the Institute for Clinical Evaluative Sciences (ICES). Event rates for the primary and secondary outcomes will be described using frequencies and proportions with 95% CIs. Intracluster and interperiod correlation coefficients will be calculated from population-level data available at ICES.

Ethics and dissemination The study protocol has been approved by the Ottawa Health Science Research Ethics Board. The FLUID pilot will determine feasibility, and ICES data across all potential sites in Ontario will allow calculation of sample size parameter estimates to inform the design and implementation of the large trial.

Trial registration number NCT02721485; Pre-results.

  • crystalloid fluid
  • ringer’s lactate
  • cluster cross over rct
  • fluid therapy
  • 0.9% Saline

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors LM, MT and DAF: conceived the project idea. LM: created the initial draft of the manuscript. All authors contributed to the development of the trial protocol; critical revisions and approved the final version of the manuscript.

  • Funding The FLUID pilot trial was funded by the Canadian Institutes for Health Research and the TOHAMO Innovation Fund Competition who did not contribute to the design of the FLUID pilot protocol.

  • Competing interests None declared.

  • Ethics approval Ottawa Health Science Network Research Ethics Board.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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