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The CALORIES trial: statistical analysis plan.

Sheila E Harvey1, Francesca Parrott2, David A Harrison2

  • 1Intensive Care National Audit and Research Centre, London, United Kingdom. kathy.rowan@icnarc.org.

Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine
|December 2, 2014
PubMed
Summary
This summary is machine-generated.

The CALORIES trial will compare parenteral versus enteral nutrition in critically ill patients. Statistical analysis will focus on 30-day mortality to determine the optimal nutritional support route.

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Area of Science:

  • Critical care medicine
  • Clinical nutrition
  • Health economics

Background:

  • The CALORIES trial is a UK-based, multicenter, randomized controlled trial (RCT).
  • It compares early parenteral nutrition (PN) versus early enteral nutrition (EN) in critically ill adult patients.
  • The study addresses the need for evidence on optimal nutritional support routes in intensive care.

Purpose of the Study:

  • To detail the statistical analysis plan for evaluating clinical effectiveness in the CALORIES trial.
  • To outline primary and secondary outcome measures and analysis methods.
  • To ensure transparency by publishing the plan before data inspection.

Main Methods:

  • The primary outcome is 30-day all-cause mortality.
  • Analysis includes Fisher's exact test for relative risk and absolute risk reduction.
  • Prespecified subgroup analyses consider age, malnutrition, illness severity, ventilation, cancer, and timing of nutritional support.

Main Results:

  • Primary analysis focuses on 30-day mortality comparing parenteral and enteral nutrition.
  • Secondary analyses will adjust for baseline covariates.
  • Subgroup analyses will explore differential effects across patient characteristics.

Conclusions:

  • A comprehensive statistical analysis plan has been developed and published for the CALORIES trial.
  • This adheres to best practices for transparency and rigor in clinical trials.
  • The plan guides the evaluation of early nutritional support strategies in critical care.