ANZICS CTG Endorsed Study
Intensive nutrition therapy compared to usual care in critically ill adults: A randomised pilot trial
Despite observational data suggesting benefit when energy and protein delivery is optimised close to requirements, no large scale randomised controlled trials (RCTs) have confirmed improved clinical outcomes in critical illness, with some showing no effect with delayed nutrition or even harm. There are several possible reasons for the lack of observed benefit from RCTs to date; the interventions may have been applied at a time when the patient’s metabolism is not in a phase of recovery; interventions have been short in duration and; studies have not addressed what happens to nutrition intake in the post ICU period of hospitalisation in critically ill individuals.
This multicenter, prospective, parallel, RCT will recruit 240 critically ill mechanically ventilated adult patients from 12-14 sites in Australia and New Zealand who have at least 1 organ failure and have been in ICU for between 72-120 hours. The primary aim of this study is to determine whether the use of a pre-tested supplemental PN strategy in the ICU and an intensive nutrition intervention after discharge to the hospital ward is feasible and will deliver more total energy than standard nutrition care over the entire hospital stay, in critically ill patients with at least one organ system failure.
Emma Ridley (Chair), Marianne Chapman, Lee-anne Chapple, Jamie Cooper, Adam Deane, Carol Hodgson, Eliza Miller (Project Manager), Andrea Marshall, Shay McGuinness, Rachael Parke, and Andrew Udy.
Ms Victoria King
Eliza Miller (Acting)
ANZIC Research Centre, Monash University
Baxter Healthcare Corporation
This study is funded by an unrestricted grant from Baxter Healthcare ($1 852 684 USD). In-kind support for infrastructure and administrative support will be provided by the ANZIC Research Centre.
Project Status as of June 2019
The INTENT trial is currently well underway with 13 site start-ups completed, 7 sites screening and 20 patients recruited. The final INTENT site will be live and screening by the end of 2019/early 2020. It is anticipated that recruitment will be completed mid-2021.
Emma Ridley (email)