INTENT RCT
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 23 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. |  |
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: INTENT achieved 100% of target study subject enrolment on 31 January 2023 with 240 participants recruited across 23 participating hospitals in Australia and New Zealand. The primary manuscript has been published, with a further manuscript in draft.
Registration: ClinicalTrials.gov NCT03292237
Funding: INTENT is funded by an independent, unrestricted, industry grant from Baxter Healthcare Corporation.
Publications:
Ridley EJ, Bailey M, Chapman MJ, Chapple LS, Deane AM, Gojanovic M, Higgins AM, Hodgson CL, King VL, Marshall AP, Miller EG, McGuinness SP, Parke RL, Paul E, Udy AA; Australian, New Zealand Intensive Care Society Clinical Trials Group. The impact of a tailored nutrition intervention delivered for the duration of hospitalisation on daily energy delivery for patients with critical illness (INTENT): a phase II randomised controlled trial. Crit Care. 2025 Jan 6;29(1):8. doi: 10.1186/s13054-024-05189-3. PMID: 39762887; PMCID: PMC11706088.
Ridley EJ, Bailey M, Chapman M, Chapple LS, Deane AM, Hodgson C, King VL, Marshall A, Miller EG, McGuinness SP, Parke R, Udy AA, Australian and New Zealand Intensive Care Society Clinical Trials Group. Protocol summary and statistical analysis plan for Intensive Nutrition Therapy comparEd to usual care iN criTically ill adults (INTENT): a phase II randomised controlled trial. BMJ Open 2022;12:e050153. https://bmjopen.bmj.com/content/12/3/e050153