Protocol summary and statistical analysis plan for ntensive utrition herapy compard to usual care i criically 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

Journal: BMJ open 2022;12(3):e050153

PMID: 35260448

Free Full Text on HighWire View on PubMed

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.

Address: Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Department of Epidemiology and Preventative Medicine, Monash University, Melbourne, Victoria, Australia [email protected].; Nutrition Department, The Alfred Hospital, Melbourne, Victoria, Australia.; Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Department of Epidemiology and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.; Department of Medicine and Radiology, University of Melbourne, Royal Melbourne Hospital, Parkville, Victoria, Australia.; Discipline of Acute Care Medicine, University of Adelaide, Adelaide, South Australia, Australia.; Intensive Care Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.; Intensive Care Unit, The Alfred Hospital, Melbourne, Victoria, Australia.; Acute and Complex Care, Gold Coast Hospital and Health Service, Southport, Queensland, Australia.; Menzies Health Institute Queensland, Griffith University, Gold Coast Campus, Southport, Queensland, Australia.; Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.; School of Nursing, The University of Auckland, Auckland, New Zealand.

DOI: 10.1136/bmjopen-2021-050153

Link outs

Free resources

Full Text Sources:

Medical:

MeSH Terms: Adult, COVID-19, Clinical Trials, Phase II as Topic, Critical Illness, Humans, Intensive Care Units, Multicenter Studies as Topic, Northern Territory, Nutrition Therapy, Randomized Controlled Trials as Topic