Protocol summary and statistical analysis plan forIntensiveNutritionTherapy comparEd to usual care iNcriTically ill adults (INTENT): a phase II randomised controlled trial

Abstract

IntroductionIt 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 analysisThis 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 disseminationEthics 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 numberNCT03292237.

Nutrition before, during and after critical illness

“…The impact of long-term nutrition interventions on clinical outcomes has not yet been investigated and remains one of the largest evidence gaps in critical illness. However, the first trial to do so is currently underway and will complete recruitment shortly [28 ▪▪ ].…”

Nutritional issues concerning general medical ward patients: feeding patients recovering from critical illness

“…Worth mentioning is the current prospective, multicentre, unblinded, parallel-group, phase II randomized controlled trial (RCT) conducted in 23 hospitals in Australia and New Zealand by Ridley et al . They focus among other outcomes on daily energy during critical care but specifically also in the post-ICU what will deliver great insights in that neglected period during acute illness [34].…”

Indirect calorimetry: should it be part of routine care or only used in specific situations?

“…In contrast, a more recent study of 32 ICU patients did not find any correlation between muscle loss derived from computer tomography scans and energy delivery [ 35 ]. The nearly completed Intensive Nutrition In Critically Ill Adults (INTENT) trial [ 36 ▪ ], randomizing patients to an individualized and intensive whole hospital intervention, including dedicated post-ICU dietician follow-up, also includes a nested substudy of 80 patients with weekly measurements of bioimpedance spectroscopy and muscle ultrasound (NCT04896515). Although not a trial of indirect calorimetry-guided feeding, the results will shed further light on the importance of cumulative energy balance for prevention of muscle wasting.…”