Protocol summary and statistical analysis plan for I ntensive N utrition T herapy compar E d to usual care i N cri T ically ill adults (INTENT): a phase II randomised controlled trial

Emma J Ridley, Michael Bailey, Marianne Chapman, Lee-Anne S Chapple, Adam M Deane, Carol Hodgson, Victoria L King, Andrea Marshall, Eliza G Miller, S P McGuinness, Rachael Parke, Andrew A Udy, the Australian and New Zealand Intensive Care Society Clinical Trials Group, Australian and New Zealand Intensive Care Society Clinical Trials Group, Emma J Ridley, Michael Bailey, Marianne J Chapman, Lee-Anne S Chapple, Adam M Deane, Carol L Hodgson, Victoria L King, Andrea P Marshall, Eliza G Miller, Shay P McGuinness, Rachael L Parke, Andrew A Udy, Emma J Ridley, Michael Bailey, Marianne Chapman, Lee-Anne S Chapple, Adam M Deane, Carol Hodgson, Victoria L King, Andrea Marshall, Eliza G Miller, S P McGuinness, Rachael Parke, Andrew A Udy, the Australian and New Zealand Intensive Care Society Clinical Trials Group, Australian and New Zealand Intensive Care Society Clinical Trials Group, Emma J Ridley, Michael Bailey, Marianne J Chapman, Lee-Anne S Chapple, Adam M Deane, Carol L Hodgson, Victoria L King, Andrea P Marshall, Eliza G Miller, Shay P McGuinness, Rachael L Parke, Andrew A Udy

Abstract

Introduction: It is plausible that a longer duration of nutrition intervention may have a greater impact on clinical and patient-centred outcomes. The Intensive Nutrition care Therapy comparEd to usual care iN criTically ill adults (INTENT) trial will determine if a whole hospital nutrition intervention is feasible and will deliver more total energy compared with usual care in critically ill patients with at least one organ system failure.

Methods and analysis: This study is a prospective, multicentre, unblinded, parallel-group, phase II randomised controlled trial (RCT) conducted in 23 hospitals in Australia and New Zealand. Mechanically ventilated critically ill adult patients with at least one organ failure who have been in intensive care unit (ICU) for 72-120 hours and meet all of the inclusion and none of the exclusion criteria will be randomised to receive either intensive or usual nutrition care. INTENT started recruitment in October 2018 and a sample size of 240 participants is anticipated to be recruited in 2022. The study period is from randomisation to hospital discharge or study day 28, whichever occurs first, and the primary outcome is daily energy delivery from nutrition therapy. Secondary outcomes include daily energy and protein delivery during ICU and in the post-ICU period, duration of ventilation, ventilator-free days, total bloodstream infection rate and length of hospital stay. All other outcomes are considered tertiary and results will be analysed on an intention-to-treat basis.

Ethics and dissemination: Ethics approval has been received in Australia (Alfred Hospital Ethics Committee (HREC/18/Alfred/101) and Human Research Ethics Committee of the Northern Territory Department of Health (2019-3372)) and New Zealand (Northern A Health and Disability Ethics Committee (18/NTA/222). Results will be disseminated in an international peer-reviewed journal(s), at scientific meetings and via social media.

Trial registration number: NCT03292237.

Keywords: adult intensive & critical care; nutrition & dietetics; nutritional support; rehabilitation medicine.

Conflict of interest statement

Competing interests: EJR has received honorarium from Baxter Healthcare (USA and Australia), Nestle and Nutricia (Australia). EJR is supported by a National Health and Medical Research Council (NHMRC) Emerging Leadership Fellowship. LSC is supported by a NHMRC Early Career Fellowship and has received honorarium from Nutricia (Australia and Global) and Fresenius Kabi. The institution that MC is employed by has received research funding for her work from Baxter Healthcare, Fresenius Kabi, Nutricia, Takeda and Theravance, unrelated to this study. The institution that AMD is employed by has received funding from Baxter Healthcare and Fresenius Kabi unrelated to this study. CLH is supported by a National Heart Foundation Fellowship and a National Health and Medical Research Council (NHMRC) Investigator Grant. APM has received honorarium from Baxter Healthcare (Australia) and received in-kind support from Danone (Australia) for work unrelated to this study. AAU is supported by a NHMRC Early Career Fellowship, and has received honorarium from Baxter Healthcare (Australia), in addition to in-kind support (trial consumables) from Integra Lifesciences, for work unrelated to this study.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study processes from screening to study completion. CBW, calculated body weight; EN, enteral nutrition; INTENT, Intensive Nutrition care Therapy comparEd to usual care iN criTically ill adults; EN, enteral nutrition; ICU, intensive care unit; NZ, New Zealand; PN, parenteral nutrition.
Figure 2
Figure 2
Management of interventional parenteral nutrition (PN) in the intensive nutrition care arm. (A) Determining the rate of interventional PN delivery on the day of randomisation. (B) Daily adjustment of interventional PN rate.EN, enteral nutrition; PN, parenteral nutrition.
Figure 3
Figure 3
Proposed reporting of the flow of participants through the trial. ICU, intensive care unit.

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