Table 3

Table of events: intensive nutrition intervention and usual nutrition care arms

Data collected	Baseline	Day 1 —ICU D/C	Days 3, 7, 14, 21, 28	Days 7, 14, 21, 28	ICU D/C	Ward	Hospital D/C	90-day and 180-day follow-up
Screening, patient demographics and baseline data*	X
SOFA	X		X
Biochemistry†	X			X
ICU daily data‡		X
ICU discharge information§					X
Ward data¶						X
Weekly data**				X
Hospital discharge information††					X
Follow-up data‡‡								X
Escalations to nutrition care for intervention patients	All requested escalations to nutrition care for intervention patients should be recorded every day until hospital discharge, regardless of whether they were conducted or not
Adverse events/serious adverse events	Description, timing, causality and resolution of adverse events from randomisation until day 90
Protocol deviations	Major protocol deviations: Randomisation of ineligible patient Greater than 120% of an intervention participants study energy requirements delivered due to an incorrect rate of interventional PN provided Minor protocol deviations: Non-interventional PN being provided when interventional PN should have been provided Interventional PN not commenced within 2 hours of randomisation Incorrect rate of interventional PN provided Interventional PN not provided during a fasting period Study oral nutrition supplements not prescribed when oral diet commenced Study energy requirement not targeted (EN delivered higher than 25 kcal/kg CBW) Failure to complete the daily nutrition review in ICU <3 days of data collected per week on the ward

X denotes must be collected on specified time point.
*Screening, patient demographics and baseline data: Patient and nutrition characteristics collected at screening will include: length of stay in the intensive care unit; patient initials; gender; height; weight; date of birth; enteral nutrition volume delivered during the 24 hours prior to screening. Patient information collected at baseline: Location prior to admission; ICU, hospital and time and date of commencement of mechanical ventilation; Acute Physiology and Chronic Health Evaluation (APACHE) II score; APACHE III diagnosis; comorbidities; Clinical Frailty Score; Malnutrition Universal Screening Tool; commencement of renal replacement therapy prior to randomisation; date and time of first central access insertion and other central access lines; energy and protein provision from hospital admission to time of randomisation; usual living location; Ethnicity (New Zealand sites only).
†Biochemistry variables if measured as part of routine practice: alanine aminotransferase; gamma-glutamyl transferase; alkaline phosphatase; bilirubin; triglycerides.
‡ICU daily data: Nutrition data: Study energy and protein requirements; energy and protein from nutrition and energy from non-nutrition sources; causes of and periods of fasting or interruptions to EN; if receiving oral diet: diet code and diet satisfaction, prescription and consumption of study oral nutrition supplements (intervention participants) and any other prescribed oral nutrition supplements (including intolerance issues), nutrition impacting symptoms if <50% of the intended oral intake was consumed. Clinical data: prokinetics; morning blood glucose and number of episodes of hypoglycaemia; units of insulin delivered; renal replacement therapy; changes in central line or new central access insertions; infectious complications; invasive mechanical ventilation.
§ICU discharge: nutrition data: mode of nutrition delivery; completion of INTENT nutrition discharge summary (intervention participants only). Clinical data: Survival; length of mechanical ventilation; ICU mobility scale; postdischarge location.
¶Ward data: nutrition data: study energy and protein requirements; energy and protein from nutrition; mode of nutrition and volumes where appropriate; if receiving oral diet: diet code and diet satisfaction, prescription and consumption of study oral nutrition supplements (intervention participants) and any other prescribed oral nutrition supplements (including intolerance issues), nutrition impacting symptoms if <50% of the intended oral intake was consumed; causes of and periods of fasting or interruptions to EN. Clinical data: weight (if recorded); use of antimemetics/antinausea medications; infectious complications.
**Weekly data: number of dietetic reviews per week (both groups); time spent implementing on the ward (intervention patients only).
††Hospital discharge: nutrition data: mode of nutrition delivery at discharge; length of time EN and PN delivered. Clinical data: survival; postdischarge location; weight; length of stay (ICU, ward hospital)
‡‡90-day and 180-day post randomisation: survival; Clinical Frailty Score; European Quality of Life 5 Dimension 5 Level and European Quality of Life Visual Analogue Scale; World Health Organisation Disability Assessment Schedule 2.0: 12-item version; resource utilisation.
CBW, calculated body weight; D/C, Discharge; ICU, intensive care unit; PN, parenteral nutrition; SOFA, Sequential organ failure assessment.