Statistical analysis plan for the BLING III study: a phase 3 multicentre randomised controlled trial of continuous versus intermittent β-lactam antibiotic infusion in critically ill patients with sepsis

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; For the BLING III Investigators

doi:10.51893/2021.3.OA4

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Statistical analysis plan for the BLING III study: a phase 3 multicentre randomised controlled trial of continuous versus intermittent β-lactam antibiotic infusion in critically ill patients with sepsis

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Statistical analysis plan for the BLING III study: a phase 3 multicentre randomised controlled trial of continuous versus intermittent β-lactam antibiotic infusion in critically ill patients with sepsis

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, …

Critical care and resuscitation, Vol.23(3), pp.273-284

01/09/2021

DOI: https://doi.org/10.51893/2021.3.OA4

PMID: 38046078

Résumé

Original

Background: 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.

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Titre: Statistical analysis plan for the BLING III study: a phase 3 multicentre randomised controlled trial of continuous versus intermittent β-lactam antibiotic infusion in critically ill patients with sepsis
Créateurs - sans rôle: Laurent Billot - George Institute for Global Health, Sydney, NSW, Australia. Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia
Jeffrey Lipman - The University of Queensland
Stephen J. Brett - Department of Anaesthesiology, Critical Care and Emergency Medicine, CHU Nîmes, University Montpellier, Nîmes, France. Imperial College Healthcare NHS Trust, London, United Kingdom. Department of Surgery and Cancer, Imperial College London, London, United Kingdom
Jan J. De Waele - Ghent University Hospital
Menino Osbert Cotta - The University of Queensland
Joshua S. Davis - Global and Tropical Health Division, Menzies School of Health Research, Darwin, NT, Australia. Department of Infectious Diseases, John Hunter Hospital, Newcastle, NSW, Australia
Simon Finfer - George Institute for Global Health, Sydney, NSW, Australia. Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, St Leonards, NSW, Australia. School of Public Health, Imperial College London, London, United Kingdom
Naomi E. Hammond - UNSW Sydney
Serena Knowles - George Institute for Global Health, Sydney, NSW, Australia
Shay McGuinness - Auckland City Hospital, Auckland, New Zealand
John Myburgh - George Institute for Global Health, Sydney, NSW, Australia. Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia
David L. Paterson - Royal Brisbane and Women’s Hospital, Brisbane, QLD, Australia. University of Queensland, Brisbane, QLD, Australia
Sandra Peake - Queen Elizabeth Hospital, Adelaide, SA, Australia. School of Medicine, University of Adelaide, Adelaide, SA, Australia. School of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia
Dorrilyn Rajbhandari - George Institute for Global Health, Sydney, NSW, Australia
Andrew Rhodes - St George’s University Hospitals NHS Foundation Trust
Jason A. Roberts - Royal Brisbane and Women’s Hospital, Brisbane, QLD, Australia. University of Queensland, Brisbane, QLD, Australia. Department of Anaesthesiology, Critical Care and Emergency Medicine, CHU Nîmes, University Montpellier, Nîmes, France
Claire Roger - Department of Anaesthesiology, Critical Care and Emergency Medicine, CHU Nîmes, University Montpellier, Nîmes, France
Charudatt Shirwadkar - Blacktown Hospital, Sydney, NSW, Australia
Therese Starr - Royal Brisbane and Women's Hospital
Colman Taylor - George Institute for Global Health, Sydney, NSW, Australia. Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia
Joel M. Dulhunty - The University of Queensland
For the BLING III Investigators
Détails de publication: Critical care and resuscitation, Vol.23(3), pp.273-284
Éditeur: Elsevier
Nombre de pages: 12
Identifiants: 99139893309311
Unité académique: Initial MAnagement & prevent of acute orGan failures IN critically ill patiEnts - IMAGINE
Langue: English
Type de ressource: Journal article