The Intensive Nutrition Therapy comparEd to usual care iN criTically ill adults - a randomised controlled trial
INTENT is a multicentre, prospective, parallel, randomised controlled trial in 240 critically ill adults from 16 hospitals in Australia and New Zealand.
Goals: The primary aim is to determine whether the use of a pre-tested supplemental parenteral nutrition (PN) strategy in the Intensive Care Unit (ICU) and an intensive nutrition intervention after discharge to the hospital ward, will deliver more total energy than standard nutrition care over the entire hospital stay.
A further aim is to develop a research program that will determine whether optimisation of energy and protein to critically ill patients over the entire period of hospitalisation improves clinically-meaningful outcomes.
Rationale: Nutrition is a commonly provided therapy in critical illness, but data about its effectiveness is sparse. It is plausible that interventions focussed on energy delivery in other trials have been applied too early in ICU admission, and not continued for long enough to see an effect on important clinical outcomes. And importantly, no study has ever investigated the period after ICU, when the patient is transferred to the ward. This is an important period in recovery, but often forgotten in terms of nutrition rehabilitation. Our group recently conducted a study of a supplemental PN strategy applied over 7 days in 100 critically ill ICU patients. The supplemental PN strategy significantly increased patients' energy and protein delivery close to estimated requirements compared to usual care. The INTENT study will aim to build on this idea and address some of the limitations in previous work, by delivering the supplemental PN strategy in ICU and a tailored intensive nutrition intervention on the post-ICU ward until day 28 or ICU discharge (whichever comes first). An intervention of this nature, applied over the whole hospital stay in critically ill adults has never been attempted before.
Study Progress: We have recruited close to 80 participants from 12 hospitals across Australia and New Zealand. We have a further 4 sites commencing the study prior to the end of 2020, and remaining sites will commence early 2021. Recruitment is expected to be complete by the end of 2021. Keep up to date with our progress and study updates on Twitter @INTENTnutrition
We are seeking expressions of interest from sites who are able to commence the study by early 2021. If you think your hospital would be interested in participating in this exciting and collaborative nutrition study, please contact the project manager (details below).
Data Entry Webpage: https://www.intenttrial.org.au
Registration: ClinicalTrials.gov NCT03292237
Funding: INTENT is funded by an independent, unrestricted, industry grant from Baxter Healthcare Corporation.
Co-enrolment: Co-enrolment in non-nutritional studies will be considered by the Management Committee as requested. Co-enrolment in any other nutritional study is not permitted.
Contact: For further information about this study, please contact the ANZIC-RC INTENT Project Manager, Eliza Miller, by email.