TARGET Protein: the effect of augmented administration of enteral protein to critically ill adults on clinical outcomes—statistical analysis plan for a cluster randomized, cross-sectional, double cross-over, clinical trial

TARGET Protein: the effect of augmented administration of enteral protein to critically ill adults on clinical outcomes—statistical analysis plan for a cluster randomized, cross-sectional, double cross-over, clinical trial

Abstract Background The TARGET Protein trial will evaluate the effect of greater enteral protein delivery (augmented protein) on clinical outcomes of critically ill adult patients when compared to usual care. Objective To describe the statistical analysis plan for the TARGET Protein trial. Methods T...

Full description

Saved in:
Bibliographic Details
Main Authors: Sophie Zaloumis, Matthew J. Summers, Jeffrey J. Presneill, Rinaldo Bellomo, Lee-anne S. Chapple, Marianne J. Chapman, Adam M. Deane, Suzie Ferrie, Craig French, Sally Hurford, Nima Kakho, Matthew J. Maiden, Stephanie N. O’Connor, Sandra L. Peake, Emma J. Ridley, An Tran-Duy, Patricia J. Williams, Paul J. Young, Amalia Karahalios, on behalf of the TARGET Protein Investigators, the Australian, New Zealand Intensive Care Society Clinical Trials Group
Format: Article
Language:English
Published: BMC 2025-02-01
Series:Trials
Subjects:
Intensive care
Dietary protein
Cluster-randomized
Cross-over
Trial
Online Access:https://doi.org/10.1186/s13063-025-08759-0
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Abstract Background The TARGET Protein trial will evaluate the effect of greater enteral protein delivery (augmented protein) on clinical outcomes of critically ill adult patients when compared to usual care. Objective To describe the statistical analysis plan for the TARGET Protein trial. Methods TARGET Protein is a cluster randomized, cross-sectional, double cross-over, open-label, registry-embedded, pragmatic clinical trial conducted across Australia and New Zealand. The trial randomized eight intensive care units (ICU) to receive enteral formula containing either higher dose enteral protein (augmented protein) or usual dose protein in a 1:1 ratio. Each ICU received one trial formula for a 3-month period and then switched to the alternate formulae. This sequence was repeated, for a total trial length of 12 months. The primary outcome is the number of days free of the index hospital and alive at day 90. Secondary outcomes include proportion of patients alive at day 90, survivor-only analysis of days free of the index hospital at day 90, duration of invasive ventilation, ICU and hospital length of stay, incidence of tracheostomy insertion, renal replacement therapy, and discharge destination. The statistical methods and models which will be used to estimate the effects for the primary and secondary outcomes are described. All statistical models will account for the cluster-randomized cross-over design to ensure correct estimation of the 95% confidence intervals. Trial enrolment is complete with 3412 patients enrolled. Data linkage is ongoing. Conclusion This statistical analysis plan enables transparent reporting of the TARGET Protein trial. It will reduce the risk of potential selective reporting biases. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12621001484831). Registered on November 1, 2021.
ISSN:1745-6215

Similar Items