ANZICS CTG Endorsed Study

INTENT

Intensive nutrition therapy compared to usual care in critically ill adults: a randomised pilot trial

Study Description

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 multicentre, prospective, parallel, RCT will recruit 240 critically ill mechanically ventilated adult patients from 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.

Management Committee

Emma Ridley (Chair), Marianne Chapman, Lee-anne Chapple, Jamie Cooper, Adam Deane, Carol Hodgson, Victoria King (Project Manager), Andrea Marshall, Shay McGuinness, Rachael Parke, and Andrew Udy.

Administering Institution

ANZIC Research Centre, Monash University

Collaborators

Baxter Healthcare Corporation

Sample Size

240 patients

Funding

This study is funded by an unrestricted grant from Baxter. In kind support for infrastructure and administrative support will be provided by the ANZIC Research Centre.

Project Status as of June 2018

Recruitment commenced October 2018 and four patients have been randomised. All 14 INTENT sites will be actively recruiting participants by early 2019. Recruitment is expected to be completed late 2020.

Contact

Emma Ridley (email)

Reference

CTG1718-10
NCT03292237