TY - JOUR
T1 - The plasma-lyte 148 versus saline (PLUS) statistical analysis plan
T2 - A multicentre, randomised controlled trial of the effect of intensive care fluid therapy on mortality
AU - Billot, Laurent
AU - Bellomo, Rinaldo
AU - Gallagher, Martin
AU - Gattas, David
AU - Hammond, Naomi E.
AU - Mackle, Diane
AU - Micallef, Sharon
AU - Myburgh, John
AU - Navarra, Leanlove
AU - Saxena, Manoj
AU - Taylor, Colman
AU - Young, Paul J.
AU - Finfer, Simon
AU - on behalf of the PLUS Study investigators the ANZICS Clinical Trials Group
N1 - Funding Information:
Acknowledgements: A series of mock tables and figures is available online with the extended version of the PLUS study Statistical Analysis Plan at https://osf.io/8gk3n. Our study is funded by the Australian National Health and Medical Research Council (Project Grant 1101765) and the Health Research Council of New Zealand (Project Grant 16/09). Baxter Healthcare will provide the blinded study fluids for the trial and will manage the warehousing and distribution of the fluids. The data will be managed, analysed and reported independent of Baxter Healthcare and the funding agencies. The full list of participating sites and investigators is available in the Online Appendix.
Funding Information:
A series of mock tables and figures is available online with the extended version of the PLUS study Statistical Analysis Plan at https://osf.io/8gk3n. Our study is funded by the Australian National Health and Medical Research Council (Project Grant 1101765) and the Health Research Council of New Zealand (Project Grant 16/09). Baxter Healthcare will provide the blinded study fluids for the trial and will manage the warehousing and distribution of the fluids. The data will be managed, analysed and reported independent of Baxter Healthcare and the funding agencies. The full list of participating sites and investigators is available in the Online Appendix.
Publisher Copyright:
© 2021, College of Intensive Care Medicine. All rights reserved.
PY - 2021/3
Y1 - 2021/3
N2 - Background and objective: The Plasma-Lyte 148 versus Saline (PLUS) study is a prospective, multicentre, parallel-group, concealed, blinded, randomised controlled trial comparing the effect of Plasma-Lyte 148 versus 0.9% sodium chloride (saline) for fluid resuscitation and other fluid therapy on 90-day mortality among critically ill adults requiring fluid resuscitation. The original target for recruitment was 8800 participants, which was reduced to 5000 participants following the onset of the coronavirus disease 2019 (COVID-19) pandemic in 2020. This article describes the statistical analysis plan for the PLUS study. Methods: The statistical analysis plan was developed by the study statistician, chief investigator, and project manager, and was approved by the Management Committee before unblinding. The plan describes in detail the analysis of baseline characteristics, process measures, and outcomes, including covariate adjustments, subgroup analyses, missing data handling, and sensitivity analyses. Results and conclusions: A statistical analysis plan for the PLUS study was developed. This pre-specified plan accords with high quality standards of internal validity and should minimise future analysis bias.
AB - Background and objective: The Plasma-Lyte 148 versus Saline (PLUS) study is a prospective, multicentre, parallel-group, concealed, blinded, randomised controlled trial comparing the effect of Plasma-Lyte 148 versus 0.9% sodium chloride (saline) for fluid resuscitation and other fluid therapy on 90-day mortality among critically ill adults requiring fluid resuscitation. The original target for recruitment was 8800 participants, which was reduced to 5000 participants following the onset of the coronavirus disease 2019 (COVID-19) pandemic in 2020. This article describes the statistical analysis plan for the PLUS study. Methods: The statistical analysis plan was developed by the study statistician, chief investigator, and project manager, and was approved by the Management Committee before unblinding. The plan describes in detail the analysis of baseline characteristics, process measures, and outcomes, including covariate adjustments, subgroup analyses, missing data handling, and sensitivity analyses. Results and conclusions: A statistical analysis plan for the PLUS study was developed. This pre-specified plan accords with high quality standards of internal validity and should minimise future analysis bias.
UR - http://www.scopus.com/inward/record.url?scp=85119613132&partnerID=8YFLogxK
U2 - 10.51893/2021.1.oa2
DO - 10.51893/2021.1.oa2
M3 - Article
AN - SCOPUS:85119613132
SN - 1441-2772
VL - 23
SP - 24
EP - 31
JO - Critical Care and Resuscitation
JF - Critical Care and Resuscitation
IS - 1
ER -