A Hospital-Wide Open-Label Cluster Crossover Pragmatic Comparative Effectiveness Randomized Trial Comparing Normal Saline to Ringer’s Lactate: Protocol and Statistical Analysis Plan of The FLUID Trial

Julia F Shaw   ^{1, 2} , MSc ;   Yongdong Ouyang   ^{1, 2} , PhD ;   Dean A Fergusson   ^{1, 2} , MHA, PhD ;   Tracy McArdle   ¹ , BSCN ;   Claudio Martin   ³ , MD ;   Deborah Cook   ⁴ , MSc, MD ;   Ian D Graham   ^{1, 2, 5} , MA, PhD ;   Steven Hawken   ^{1, 2, 6} , PhD ;   Colin J L McCartney   ⁷ , MBChB, PhD ;   Kusum Menon   ⁸ , MSc, MD ;   Raphael Saginur   ⁹ , MD ;   Andrew Seely   ^{1, 10} , MD, PhD ;   Ian Stiell   ^{1, 5} , MSc, MD ;   Alison Fox-Robichaud   ¹¹ , MSc, MD ;   Shane English   ^{1, 2, 12} , MSc, MD ;   John Marshall   ¹³ , MD ;   Kednapa Thavorn   ^{1, 2, 6} , PhD ;   Monica Taljaard   ^{1, 2} , PhD ;   Lauralyn A McIntyre   ^{1, 2, 12} , MSc, MD ;   Canadian Critical Care Trials Group   ¹⁴

¹ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada

² School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada

³ Division of Critical Care Medicine, London Health Sciences Centre, Western University, London, ON, Canada

⁴ Departments of Medicine, Clinical Epidemiology and Biostatistics, St. Joseph’s Healthcare Hamilton, McMaster University, Hamilton, ON, Canada

⁵ Department of Emergency Medicine, University of Ottawa, Ottawa, ON, Canada

⁶ ICES, University of Ottawa, Ottawa, ON, Canada

⁷ Department of Anesthesiology, The Ottawa Hospital, Ottawa, ON, Canada

⁸ Children’s Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada

⁹ Department of Medicine, Infectious Diseases, The Ottawa Hospital, Ottawa, ON, Canada

¹⁰ Department of Surgery, The Ottawa Hospital, Ottawa, ON, Canada

¹¹ Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada

¹² Department of Medicine, Division of Critical Care, University of Ottawa, Ottawa, ON, Canada

¹³ Department of Surgery, St. Michael’s Hospital, Toronto, ON, Canada

¹⁴ See Acknowledgments, Ottawa, ON, Canada