The Effect of early intravenouS amino acid SupplemENtation in criTically Ill pAtients with normaL kidney function:a multi-centered, randomized, parallel-controlled trial

Study design: a multi-centered, randomized, parallel-controlled trial

Trial status: recruitment completed

Overall trial start date: 01/06/2020

Overall trial end date: 01/06/2024

Recruitment start date: 01/01/2021




The characteristic hypercatabolic state of critical illness, with severe disturbances in amino acid metabolism, has long been considered an important contributor to ICU-acquired weakness. Stress-induced catabolism of muscular proteins is thought to provide a necessary source of amino acids that allows sustained gluconeogenesis and synthesis of acute phase proteins in a condition of limited intake. With ongoing stress, muscle catabolism persists and may culminate in a profound loss of lean body mass.


The 2016 American Society of Critical Care Medicine guidelines for the provision of nutrition support have emphasized the importance of protein intake during critical illness by recommending daily doses as high as two grams per kilogram actual body weight per day. However, because there are no RCTs demonstrating patient-centered benefits arising from this higher protein target, many experts disagree with this recommendation and call for more conservative practice. Recently, Zhu et al published the results of a focused re-analysis of a major multi-centre clinical trial demonstrating that higher protein intake (2g/kg/day) may significantly reduce 90-day mortality by up to 8% in critically ill patients with normal renal function (P = 0.034) [7]. The analysis presented by Zhu et al constitutes the largest group of critically ill patients randomised to receive increased protein intake versus standard care. They were recruited from 16 ICUs throughout Australia and New Zealand. Given the importance of the benefits demonstrated in the paper by Zhu et al, and the lack of RCTs supporting expert recommendations for protein dosing, Zhu et al’s results warrant confirmation in a well-conducted large-scale RCT.