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
Authors: Ridley Emma J. , Bailey Michael , Chapman Marianne J. , Chapple Lee-anne S. , Deane Adam M. , Gojanovic Marlene , Higgins Alisa M. , Hodgson Carol L. , King Victoria L. , Marshall Andrea P. , Miller Eliza G. , McGuinness Shay P. , Parke Rachael L. , Paul Eldho , Udy Andrew A. ,   The Australian, New Zealand Intensive Care Society Clinical Trials Group, Ridley Emma J. , Bailey Michael , Chapman Marianne J. , Chapple Lee-anne S. , Deane Adam M. , Gojanovic Marlene , Higgins Alisa M. , Hodgson Carol L. , King Victoria L. , Marshall Andrea P. , Miller Eliza G. , McGuinness Shay P. , Parke Rachael L. , Paul Eldho , Udy Andrew A. , Ali Farisha , Baskett Rebecca , Butler Magdalena , Cowdrey Keri-Anne , Gilder Eileen , Gillan Lydia , Koorts Su-Zahn , Mason Brittany , McMahon Ellie , McGuinness Shay , O’Connor Karina , Parke Rachael , Robertson Melissa , Ryan Samantha , Small Anna , Xia Andrew , Berner Megan , Choong Christine , Eastwood Glenn , Hamilton Kate , Jones Daryl , Peck Leah , Young Helen , Ballantyne Lauren , Boschert Catherine , Knott Cameron , Roberts Bridget , Smith Julie , Flick Zoe , Gandhi Kalpesh , Hannah Barbara , Li Yvonne , Nand Kiran , Sara Treena , Wei Sylvia , Briek Lina , Duke Graeme , Gellie Kym , Hunter Stephanie , Robertson Nicole , Barrett Jonathan , Cleeve Brydie , Guille Caroline , Hanlon Gabrielle , Jelly-Butterworth Sarah , O’Donnell Julie , Zoanetti Carmel , Coram Zhoe , Edis Karen , Gomez Mike , Goodman Alice , Haji Kavi , Moss Jenny , Prendergast Jodie , Tam Janet , Tiruvoipati Ravindranath , Turnbull Fiona , Cussen Julie , Gough Maimoonbe , Lovelock Sarah , Mahoney Lisa , Marshall Andrea , Pearson David , Tallott Mandy , Ainslie Emily , Flynn Kate , Gordon Kerri , Stewart Tim , Telfer Larissa , Williams Victoria , Biradar Vishwanath , Chahine Hanaa , Jessen Edda , Kapsambelis Matia , Lydyard Melissa , Martin Ashlee , Puccini Julie , Soar Natalie , Sommerfield Leah , Bartholomew Bronwyn , Collins Peter , Filet Claire , Finnis Mackenzie , Jobber Chloe , Jongebloed Katherine , Leditschke Isabel Anne , Browning Kimberley , Chang Jennifer , Girijadevi Dinu , Hussein Areege , Lai Vivian , Song Rima , Williams Tony , de Silva Oshara , Gervasoni Ashlee , Hall Carolyn , Hanna Lauren , Phillips Sheree , Shehabi Yahya , Gresham Rebecca , Jamei Matin , Joy Sheeja , Lowrey Julie , Masters Kristy , Seppelt Ian , Tu Wendy , Whitehead Christina , Aboltins Tina , Collins Hayley , Evans Rachael , Ghosh Angaj , Said Simone , Tsang Vivian , De Groot Lynette , Doola Ra’eesa , Harward Meg , Jones Cassie , Mackay Josephine , Meyer Jason , Takefala Tahnie , Walsham James , Baker Stuart , Khoo Anthony , Lewis Shannon , Nissen Alyce , Tabah Alexis , Wiese Alicia , Campbell Lewis , Chin Miriam , Garcia Rebecca , Smyth Kirsty , Thallon Annabel , Bidgood Emma , Browne Jessica , Byrne Kathleen , Deane Adam , Fetterplace Kate , Griffin Hilda , Phillips Sarah , Wittholz Kym , Board Jasmin , Bretag Peta , Burrell Aidan , Cunningham Adam , Gantner Dashiell , Hanna Ramez , Lambell Kate , Lay Karina , Licari Elisa , Loh Lee Lin , Martin Emma , McCracken Phoebe , Obeid Jenna , Rabel Caitlin , Thanhauser Peter , Udy Andrew , Vadiveloo Chloe , Wong Cyndi , Young Meredith , French Cameron , Hollis Greta , Powlesland Adrian , Shekar Kiran , Vasudevan Marion , Whitmore Emma , Direen Tennealle , Hatzi Martine , Kurenda Cathy , Peake Sandra , Thatcher Amber , Williams Patricia , Horton Michelle , Kakho Nima , Maiden Matthew , Salerno Tania , Trickey Jemma 
Published: January 2025

Abstract
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.