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Trial registered on ANZCTR
Registration number
ACTRN12620000845932
Ethics application status
Approved
Date submitted
12/06/2020
Date registered
27/08/2020
Date last updated
4/08/2024
Date data sharing statement initially provided
27/08/2020
Date results provided
31/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluating nutrient regulation in ICU survivors: A prospective cohort study
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Scientific title
Nutrient regulation in ICU survivors: Investigating psychological factors associated with nutrient intake in a prospective cohort
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Secondary ID [1]
301432
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Post-Intensive Care Nutrition
317723
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Critical illness
317726
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Condition category
Condition code
Diet and Nutrition
315797
315797
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This study will observe the energy intake from a weighed, soft diet, energy buffet in adult survivors of critical illness, when compared to general hospitalised patients and healthy controls.
Following an overnight fast, participants will have their energy expenditure measured via indirect calorimetry using a metabolic cart (Quark CPET, Cosmed) over a 30-minute period, via a canopy hood. Objective measures of taste thresholds will be assessed using edible taste strips. Appetite will be assessed using a set of Visual Analogue Scales (VAS) at three timepoints (-30min (fasting), 180 mins (prior to buffet), 210 mins (post buffet)). Each VAS will consist of a 100 mm horizontal line, where 0 mm represents ‘sensation not felt at all’ and 100 mm ‘sensation felt the greatest’. The participant will be required to place a vertical mark along the line to indicate the strength of each sensation. Participants will be asked to consume 200 ml of a liquid test meal (Ensure Original (Abbott, 237 ml, 920 kJ, 9 g protein, 33 g carbohydrate, 6 g fat)) over a 5-minute interval, t= 0 mins when the liquid test meal has been consumed. Blood samples will be taken from a venous catheter every 15 minutes for the first hour and every 30 minutes thereafter for the study period. The resulting plasma/serum will be stored at -70º C for subsequent analysis. Hormones associated with appetite control will be analysed at each time-point over the study period, including ghrelin, leptin, insulin, peptide YY (PYY) and cholecystokinin (CCK). Antral area will be assessed using ultrasonography every 15 minutes for the first hour and at 30 minute intervals thereafter until 180 mins. At t=180 minutes, participants will be provided with a standard energy buffet (2666kcal, 123g protein, 81g fat, and 342g carbohydrate) modified to allow for soft diet, which has been validated to assess nutrient intake. Participants will be instructed to consume this buffet until they are comfortably full, within a 30 minute period. The amount of calories and macronutrients consumed will be quantified using Foodworks dietary analysis software (Xyris, Brisbane, Australia). The time taken to reach the point of satisfaction with this meal will also be recorded. The total duration for completion of all study specific procedures will be approximately 5 hours.
During the study day, a 24-hour recall of intake from the previous day will be conducted by a trained dietitian. Additionally, a Gastrointestinal Symptoms Questionnaire and a Patient-Generated Subjective Global Assessment (PG-SGA) will be used to assess the presence of gastrointestinal symptoms relating to barriers effecting nutritional intake, for example nausea, loss of appetite, bloating, problems swallowing, requirement for feeding assistance and dry mouth . Quality of life questionnaires will also be used: EQ-5D-5L and SF-36.
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Intervention code [1]
317744
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Diagnosis / Prognosis
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Comparator / control treatment
The study will require two comparator groups, who will follow the same study procedures as the critically ill patient group.
• Group 2: General hospitalised patients:
Patients admitted to a RAH General Medical Unit will be screened for eligibility on admission and recruited prospectively if able to complete measures within 7 days of admission.
• Group 3: Healthy participants:
Healthy subjects will be recruited from an existing pool of healthy volunteers or by flyers placed around the major Hospitals in Adelaide, the University of Adelaide and the University of South Australia, or, if required, by classified advertisements placed in local newspapers or online noticeboards.
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Control group
Active
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Outcomes
Primary outcome [1]
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Energy intake from weighed energy buffet meal.
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Assessment method [1]
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Timepoint [1]
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180 mins post test-meal consumption.
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Secondary outcome [1]
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Cross-sectional antral area as a measure of satiety, measured by ultrasonography.
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Assessment method [1]
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Timepoint [1]
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Antral area will be assessed using ultrasonography immediately before the test drink,
immediately following the test drink (t=0 mins), every 15 minutes for the first hour and at 30 minute intervals thereafter until the buffet meal is provided (t=180 mins).
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Secondary outcome [2]
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Self-perceived appetite as per visual analogue scale.
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Assessment method [2]
383541
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Timepoint [2]
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At three timepoints during the study:
1. Fasted state (t=-10 mins)
2. Delayed post-prandial phase (t=180 mins)
3. Immediate post-prandial phase (t=210 mins).
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Secondary outcome [3]
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Gastrointestinal symptoms self reported in a questionnaire (PG-SGA).
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Assessment method [3]
383542
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Timepoint [3]
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Assessed once during the study day.
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Secondary outcome [4]
383545
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Taste thresholds assessed by edible taste strips placed on the tongue.
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Assessment method [4]
383545
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Timepoint [4]
383545
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Assessed once at the start of the study day, prior to the test liquid meal, when the patient is fasted.
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Secondary outcome [5]
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Quality of life will be assessed using the EQ-5D-5L and SF-36 questionnaires.
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Assessment method [5]
383546
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Timepoint [5]
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Assessed once during the study day.
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Secondary outcome [6]
384383
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Area under the concentration time curves of grehlin concentration, from venous blood samples.
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Assessment method [6]
384383
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Timepoint [6]
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Every 15 minutes for the first hour and every 30 minutes thereafter for the study period, prior to administering the buffet meal (-10, 15, 30, 45, 60, 90, 120, 150, 180 mins).
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Secondary outcome [7]
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Area under the concentration time curves of leptin concentration, from venous blood samples.
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Assessment method [7]
384384
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Timepoint [7]
384384
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Every 15 minutes for the first hour and every 30 minutes thereafter for the study period, prior to administering the buffet meal (-10, 15, 30, 45, 60, 90, 120, 150, 180 mins).
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Secondary outcome [8]
384385
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Area under the concentration time curves of insulin concentration, from venous blood samples.
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Assessment method [8]
384385
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Timepoint [8]
384385
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Every 15 minutes for the first hour and every 30 minutes thereafter for the study period, prior to administering the buffet meal (-10, 15, 30, 45, 60, 90, 120, 150, 180 mins).
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Secondary outcome [9]
384386
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Area under the concentration time curves of peptide YY (PYY) concentration, from venous blood samples.
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Assessment method [9]
384386
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Timepoint [9]
384386
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Every 15 minutes for the first hour and every 30 minutes thereafter for the study period, prior to administering the buffet meal (-10, 15, 30, 45, 60, 90, 120, 150, 180 mins).
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Secondary outcome [10]
384387
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Area under the concentration time curves of cholecystokinin (CCK) concentration, from venous blood samples.
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Assessment method [10]
384387
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Timepoint [10]
384387
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Every 15 minutes for the first hour and every 30 minutes thereafter for the study period, prior to administering the buffet meal (-10, 15, 30, 45, 60, 90, 120, 150, 180 mins).
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Secondary outcome [11]
384388
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Area under the concentration time curves of glucose concentration, from venous blood samples.
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Assessment method [11]
384388
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Timepoint [11]
384388
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Every 15 minutes for the first hour and every 30 minutes thereafter for the study period, prior to administering the buffet meal (-10, 15, 30, 45, 60, 90, 120, 150, 180 mins).
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Secondary outcome [12]
385131
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24-hour recall of diary intake
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Assessment method [12]
385131
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Timepoint [12]
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Dietary intake from day prior to study
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Eligibility
Key inclusion criteria
Group 1: Critically ill patients:
Patients admitted to the Royal Adelaide Hospital ICU will be screened for eligibility on admission and recruited prospectively on ICU discharge if able to complete measures within 7 days of ICU discharge.
Inclusions:
• Adults (18 years and above)
• Were admitted to the RAH ICU during this hospital admission
• ICU length of stay >72 hours
Group 2: General hospitalised patients:
Patients admitted to a RAH General Medical Unit will be screened for eligibility on admission and recruited prospectively if able to complete measures within 7 days of admission.
Inclusions:
• Adults (18 years and above)
• Admitted to the RAH general medicine ward
Group 3: Healthy participants:
25 age-, sex-, and BMI-matched healthy participants will be recruited from an existing pool of healthy volunteers or by flyers.
Inclusion:
• Adults (18 years and above)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria for Group 1 and 2:
• Patients unable to follow commands and give informed consent (i.e. head injured, subarachnoid haemorrhage and history of dementia)
• Unable to consume energy buffet e.g. remains on enteral or parenteral nutrition, thickened fluids/texture modified diet, vegan/vegetarian, lactose/gluten intolerant
• Major gastrointestinal surgery on this admission or previous admissions
• Pregnancy
Additional exclusion criteria have been included to ensure the healthy participant cohort recruited is representative of a healthy population.
Exclusion for group 3:
• Inability to give informed consent
• Significant illness
• Smokers (cigarettes/cigars/marijuana)
• Intake of >2 standard drinks on >5 days per week
• Intake of >4 cups of caffeinated drinks per day
• Intake of any illicit substance
• Unable to consume energy buffet e.g. thickened fluids/texture modified diet, vegan/vegetarian, lactose/gluten intolerant
• Significant gastrointestinal symptoms, disease or surgery (apart from uncomplicated appendectomy)
• Pregnancy
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
The primary outcome will be the difference in energy intake from weighed energy buffet between the critically ill patient group and the two comparator groups (General hospitalised patients and Healthy participants). Based on our previous study in ICU survivors, the standard deviation in calorie intake from the weighed buffet meal was 346 kcal. A sample size of 25 ICU patients and 25 ward patients will provide 80% power at the 0.05 significance level, to detect a difference in calorie intake of 280 kcal. This was chosen a priori to be of clinical relevance and likely to lead to a meaningful effect on nutritional status.
Differences in energy intake from weighed energy buffet, gastrointestinal hormone responses and antral area will be measured using Independent samples t-tests. VAS outcomes will be analysed using repeated measures analysis of variance (RM ANOVA) with effects for group, time (baseline, delayed post-prandial, immediate post-prandial), and the group by time interaction. Significant interactions will be followed by pairwise post-hoc tests comparing between groups.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/09/2020
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Actual
6/11/2020
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Date of last participant enrolment
Anticipated
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Actual
16/12/2021
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Date of last data collection
Anticipated
30/09/2022
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Actual
16/12/2021
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Sample size
Target
75
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Accrual to date
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Final
45
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
16833
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
30474
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
305871
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Hospital
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Name [1]
305871
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Royal Adelaide Hospital Research Committee (RRC)
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Address [1]
305871
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Royal Adelaide Hospital
Port Road,
Adelaide SA 5000
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Country [1]
305871
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Australia
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Primary sponsor type
Hospital
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Name
Royal Adelaide Hospital.
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Address
Royal Adelaide Hospital
Port Road,
Adelaide SA 5000
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Country
Australia
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Secondary sponsor category [1]
306321
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None
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Name [1]
306321
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Address [1]
306321
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Country [1]
306321
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306131
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Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
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Ethics committee address [1]
306131
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Level 3, Roma Mitchell House 136 North Terrace, Adelaide SA 5000
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Ethics committee country [1]
306131
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Australia
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Date submitted for ethics approval [1]
306131
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Approval date [1]
306131
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24/02/2020
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Ethics approval number [1]
306131
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Summary
Brief summary
This exploratory single-centre study will be conducted at the Royal Adelaide Hospital, South Australia. Patients will be recruited from two locations; the intensive care and general medical units. Healthy volunteers will be recruited from existing pools or through advertisements as required. This study will recruit: 1. 25 ICU patients 2. 25 general medical patients 3. 25 healthy volunteers The primary aim of this study is to determine whether energy intake as measured from a weighed, soft diet, energy buffet is reduced in adult survivors of critical illness when compared to general hospitalised patients and healthy controls. This study will also aim to determine if there are impairments in the following mechanisms or psychological factors that regulate nutrient intake in survivors of critical illness when compared to general hospitalised patients and healthy controls: a. Fasting and post-prandial gastrointestinal hormone response b. Antral area c. Self-perceived appetite d. Gastrointestinal symptoms e. Taste threshold f. Quality of life
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Lee-anne Chapple
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Address
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Intensive Care Research
Royal Adelaide Hospital
Port Road, Adelaide 5000, South Australia
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Country
102814
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Australia
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Phone
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+61 8 7074 1763
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Lee-anne Chapple
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Address
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Intensive Care Research
Royal Adelaide Hospital
Port Road, Adelaide 5000, South Australia
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Country
102815
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Australia
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Phone
102815
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+61 8 7074 1763
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Fax
102815
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Email
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[email protected]
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Contact person for scientific queries
Name
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Lee-anne Chapple
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Address
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Intensive Care Research
Royal Adelaide Hospital
Port Road, Adelaide 5000, South Australia
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Country
102816
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Australia
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Phone
102816
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+61 8 7074 1763
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Fax
102816
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No individual participant data will be available, due to patient confidentiality.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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