• Laurent Billot, Jeffrey Lipman, Stephen J Brett, Jan J De Waele, Menino Osbert Cotta, Joshua S Davis, Simon Finfer, Naomi E Hammond, Serena Knowles, Shay McGuinness, John Myburgh, David L Paterson, Sandra Peake, Dorrilyn Rajbhandari, Andrew Rhodes, Jason A Roberts, Claire Roger, Charudatt Shirwadkar, Therese Starr, Colman Taylor, Joel M Dulhunty, and BLING III Investigators.
• George Institute for Global Health, Sydney, NSW, Australia.
• Crit Care Resusc. 2021 Sep 6; 23 (3): 273284273-284.

AbstractBackground: The β-Lactam Infusion Group (BLING) III study is a prospective, multicentre, open, phase 3 randomised controlled trial comparing continuous infusion with intermittent infusion of β-lactam antibiotics in 7000 critically ill patients with sepsis. Objective: To describe a statistical analysis plan for the BLING III study. Methods: The statistical analysis plan was designed by the trial statistician and chief investigators and approved by the BLING III management committee before the completion of data collection. Statistical analyses for primary, secondary and tertiary outcomes and planned subgroup analyses are described in detail. Interim analysis by the Data Safety and Monitoring Committee (DSMC) has been conducted in accordance with a pre-specified DSMC charter. Results and conclusions: The statistical analysis plan for the BLING III study is published before completion of data collection and unblinding to minimise analysis bias and facilitate public access and transparent analysis and reporting of study findings. Trial registration:ClinicalTrials.gov Registry NCT03212990.© 2021 College of Intensive Care Medicine of Australia and New Zealand.

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