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

doi:10.51893/2021.3.oa4

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 TaylorJoel M. Dulhunty

Global and Tropical Health

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	273-284
Number of pages	12
Journal	Critical Care and Resuscitation
Volume	23
Issue number	3
DOIs	https://doi.org/10.51893/2021.3.oa4
Publication status	Published - Sept 2021

Access to Document

10.51893/2021.3.oa4

Cite this

Billot, L., Lipman, J., Brett, S. J., De Waele, J. J., Cotta, M. O., Davis, J. S., Finfer, S., Hammond, N. E., Knowles, S., McGuinness, S., Myburgh, J., Paterson, D. L., Peake, S., Rajbhandari, D., Rhodes, A., Roberts, J. A., Roger, C., Shirwadkar, C., Starr, T., ... Dulhunty, J. M. (2021). 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. Critical Care and Resuscitation, 23(3), 273-284. https://doi.org/10.51893/2021.3.oa4

@article{88a90e36f9e346a295d78f047e261e78,

title = "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",

abstract = "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.",

author = "Laurent Billot and Jeffrey Lipman and Brett, {Stephen J.} and {De Waele}, {Jan J.} and Cotta, {Menino Osbert} and Davis, {Joshua S.} and Simon Finfer and Hammond, {Naomi E.} and Serena Knowles and Shay McGuinness and John Myburgh and Paterson, {David L.} and Sandra Peake and Dorrilyn Rajbhandari and Andrew Rhodes and Roberts, {Jason A.} and Claire Roger and Charudatt Shirwadkar and Therese Starr and Colman Taylor and Dulhunty, {Joel M.}",

year = "2021",

month = sep,

doi = "10.51893/2021.3.oa4",

language = "English",

volume = "23",

pages = "273--284",

journal = "Critical Care and Resuscitation",

issn = "1441-2772",

publisher = "Australasian Academy of Critical Care Medicine",

number = "3",

}

Billot, L, Lipman, J, Brett, SJ, De Waele, JJ, Cotta, MO, Davis, JS, Finfer, S, Hammond, NE, Knowles, S, McGuinness, S, Myburgh, J, Paterson, DL, Peake, S, Rajbhandari, D, Rhodes, A, Roberts, JA, Roger, C, Shirwadkar, C, Starr, T, Taylor, C & Dulhunty, JM 2021, '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', Critical Care and Resuscitation, vol. 23, no. 3, pp. 273-284. https://doi.org/10.51893/2021.3.oa4

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. / Billot, Laurent; Lipman, Jeffrey; Brett, Stephen J. et al.
In: Critical Care and Resuscitation, Vol. 23, No. 3, 09.2021, p. 273-284.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Statistical analysis plan for the BLING III study

T2 - A phase 3 multicentre randomised controlled trial of continuous versus intermittent β-lactam antibiotic infusion in critically ill patients with sepsis

AU - Billot, Laurent

AU - Lipman, Jeffrey

AU - Brett, Stephen J.

AU - De Waele, Jan J.

AU - Cotta, Menino Osbert

AU - Davis, Joshua S.

AU - Finfer, Simon

AU - Hammond, Naomi E.

AU - Knowles, Serena

AU - McGuinness, Shay

AU - Myburgh, John

AU - Paterson, David L.

AU - Peake, Sandra

AU - Rajbhandari, Dorrilyn

AU - Rhodes, Andrew

AU - Roberts, Jason A.

AU - Roger, Claire

AU - Shirwadkar, Charudatt

AU - Starr, Therese

AU - Taylor, Colman

AU - Dulhunty, Joel M.

PY - 2021/9

Y1 - 2021/9

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85127895321&partnerID=8YFLogxK

U2 - 10.51893/2021.3.oa4

DO - 10.51893/2021.3.oa4

M3 - Article

AN - SCOPUS:85127895321

SN - 1441-2772

VL - 23

SP - 273

EP - 284

JO - Critical Care and Resuscitation

JF - Critical Care and Resuscitation

IS - 3

ER -

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

Abstract

Access to Document

Other files and links

Fingerprint

Cite this