TARGET Protein: The effect of augmented administration of enteral protein to critically ill adults on clinical outcomes: A cluster randomised, cross-sectional double cross-over, registry-embedded, pragmatic clinical trial

None listed

An intensive care unit (ICU) stay is associated with significant muscle wasting in up to 80% of critically ill patients. This muscle wasting results in ‘ICU-acquired weakness’ that is associated with slower weaning from ventilator support, longer time to discharge alive from ICU and hospital, higher in-hospital costs which persist well after discharge from the acute care setting. Nutrition therapy, delivered as liquid nutrition via a tube into the stomach, forms usual care for critically ill patients. The provision of additional protein has the potential to attenuate muscle atrophy, and hence improve outcomes following critical illness. Current international guidelines recommend delivery of protein prescription of 1.2 - 2.0 g/kg/day or higher, but this is based on very low quality of evidence, and there is observational evidence to support both benefit and harm of augmented protein prescription. Therefore, there is a need for a high-quality randomised controlled trial of differing protein prescriptions. We propose a cluster randomised clinical trial with the aim of evaluating the effect of higher dietary protein delivery on outcomes of critically ill adult patients when compared to usual care. In this study each ICU will be randomised to one of the two study formulae for 3 months and then crosses over to the other study formulae for 3 months, which is then repeated, with each site participating for 12 months. Each eligible patient admitted to the ICU during these 3-month periods will receive the same study formula.