• Matthew J Summers, ChappleLee-Anne SLSIntensive Care Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.Discipline of Acute Care Medicine, The University of Adelaide, Adelaide, South Australia, Australia.National Health and Medical Research Council of Austr, Rinaldo Bellomo, Marianne J Chapman, Suzie Ferrie, Mark E Finnis, Craig French, Sally Hurford, Nima Kakho, Amalia Karahalios, Matthew J Maiden, Stephanie N O'Connor, Sandra L Peake, Jeffrey J Presneill, Emma J Ridley, An Tran-Duy, Patricia J Williams, Paul J Young, Sophie Zaloumis, Adam M Deane, and TARGET Protein Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group.
• Intensive Care Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
• Crit Care Resusc. 2023 Sep 1; 25 (3): 147154147-154.

BackgroundIt is unknown whether increasing dietary protein to 1.2-2.0 g/kg/day as recommended in international guidelines compared to current practice improves outcomes in intensive care unit (ICU) patients. The TARGET Protein trial will evaluate this.ObjectiveTo describe the study protocol for the TARGET Protein trial.Design Setting And ParticipantsTARGET Protein is a cluster randomised, cross-sectional, double cross-over, pragmatic clinical trial undertaken in eight ICUs in Australia and New Zealand. Each ICU will be randomised to use one of two trial enteral formulae for three months before crossing over to the other formula, which is then repeated, with enrolment continuing at each ICU for 12 months. All patients aged ≥16 years in their index ICU admission commencing enteral nutrition will be eligible for inclusion. Eligible patients will receive the trial enteral formula to which their ICU is allocated. The two trial enteral formulae are isocaloric with a difference in protein dose: intervention 100g/1000 ml and comparator 63g/1000 ml. Staggered recruitment commenced in May 2022.Main Outcomes MeasuresThe primary outcome is days free of the index hospital and alive at day 90. Secondary outcomes include days free of the index hospital at day 90 in survivors, alive at day 90, duration of invasive ventilation, ICU and hospital length of stay, incidence of tracheostomy insertion, renal replacement therapy, and discharge destination.ConclusionTARGET Protein aims to determine whether augmented enteral protein delivery reduces days free of the index hospital and alive at day 90.Trial RegistrationAustralian New Zealand Clinical Trials Registry (ACTRN12621001484831).© 2023 The Authors.

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