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

Background: Nutrition interventions commenced in ICU and continued through to hospital discharge have not been definitively tested in critical care to date. To commence a program of research, we aimed to determine if a tailored nutrition intervention delivered for the duration of hospitalisation delivers more energy than usual care to patients initially admitted to the Intensive Care Unit (ICU). Methods: A multicentre, unblinded, parallel-group, phase II trial was conducted in twenty-two hospitals in Australia and New Zealand. Adult patients, requiring invasive mechanical ventilation (MV) for 72–120 h within ICU, and receiving < 80% estimated energy requirements from enteral nutrition (EN) were included. The intervention (tailored nutrition) commenced in ICU and included EN and supplemental parenteral nutrition (PN), and EN, PN, and/or oral nutrition after liberation from MV, and was continued until hospital discharge or study day 28. The primary outcome was daily energy delivery from nutrition (kcal). Secondary outcomes included duration of hospital stay, ventilator free days at day 28 and total blood stream infection rate. Main results: The modified intention to treat analysis included 237 patients (n = 119 intervention and n = 118 usual care). Baseline characteristics were balanced; the median [interquartile range] intervention period was 19 [14–35] and 19 [13–32] days in the tailored nutrition and usual care groups respectively. Energy delivery was 1796 ± 31 kcal/day (tailored nutrition) versus 1482 ± 32 kcal/day (usual care)—adjusted mean difference 271 kcal/day, 95% CI 189–354 kcal. No differences were observed in any secondary outcomes. Conclusions: A tailored nutrition intervention commenced in the ICU and continued until hospital discharge achieved a significant increase in energy delivery over the duration of hospitalisation for patients initially admitted to the ICU. Trial registration ClinicalTrials.gov Identifier NCT03292237. First registered 25th September 2017. Last updated 10th Feb 2023.