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Trial registered on ANZCTR


Registration number
ACTRN12616000702415
Ethics application status
Approved
Date submitted
17/05/2016
Date registered
27/05/2016
Date last updated
22/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of critical illness on appetite in adult survivors
Scientific title
Evaluation of the effect of critical illness on appetite in adult survivors
Secondary ID [1] 289044 0
Nil known
Universal Trial Number (UTN)
U1111-1182-1053
Trial acronym
AACI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill 298489 0
Nutritional intake 298490 0
Appetite 298491 0
Condition category
Condition code
Diet and Nutrition 298577 298577 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention will be provided. This observational study will compare the below measures in survivors of critical illness three-months post-intensive care admission compared to a 'healthy' population.

1. Anthropometrics:
Height, weight, weight history and circumferences (hip, waist, neck)

2. 24-hour dietary recall:
A 24-hour dietary recall will be taken by a qualified Dietitian on the study day to assess intake in the preceding 24 hour period (prior to overnight fast) and entered into Foodworks dietary analysis software as a measure reflective of current energy and protein intake.

3. Oral Glucose tolerance and isotope breath tests:
All participants will have fasted overnight to allow for accurate oral glucose and gastric emptying results. Recurrent venous blood samples will be used for the analysis of insulin secretion. Breath samples will be used for the analysis of gastric emptying. For gastric emptying, a solution containing water (450ml), glucose (75g), and 13C-octanoic acid solution (100mg) will be used. The concentration of CO2 and the percentage of 13CO2 present will be measured with an isotope ratio mass spectromoter (Europa Scientific, ABCA model 20/20, Crewe UK). Blood for use in the Oral Glucose Tolerance test will be obtained through a cannula in the antecubital vein.

The time at which the glucose solution is finished by the participant is designated as Time (T)=0 min. Breath samples will be taken at at baseline, every 5 minutes for the first hour and then every 15min for the remaining 2 hour study time frame. Following measurement of CO2 and 13CO2 in the breath samples, a curve is plotted in which the area under the curve being used to calculate the gastric emptying coefficient and half emptying time. Mathematical modeling will be used in order to analyse the insulin secreting capacity with the results from the oral glucose tolerance test.

4. Measurement of blood glucose and plasma GLP-1, GIP, glucagon, and serum insulin and C-peptide concentrations:
Blood samples will be collected every 30 minutes for 3 hours through the antecubital vein cannula and analysed for blood glucose concentrations. The hormones (serum, insulin, c-peptide, and plasma glucagon, GIP & GLP-1) will also be measured at these time points.

5. Energy buffet:
An energy buffet will be provided to each participant at the end of the glucose tolerance test. This energy buffet is a standard buffet that has been validated in the assessment of energy intake in appetite and gastric emptying studies. Energy and protein consumption will be assessed using Foodworks dietary analysis software.

6. Visual analogue scales:
Visual analogue scales to assess factors that affect appetite and intake will be conducted at 3-month followup at study baseline (prior to oral glucose tolerance test in a fasted state), 15 minutes prior to the energy buffet, and at the end of the energy buffet.
Intervention code [1] 294553 0
Not applicable
Comparator / control treatment
The control group will consist of matched healthy volunteers. These participants will receive the same assessment protocol as per the post-ICU group.
Control group
Active

Outcomes
Primary outcome [1] 298079 0
To assess energy intake in survivors of critical illness when compared with that of matched healthy volunteers using a standardised energy buffet following a 12 hour overnight fasting.
Timepoint [1] 298079 0
3-months post-ICU discharge.
Secondary outcome [1] 323118 0
To assess self-reported appetite in survivors of critical illness compared to that of matched healthy controls using visual analogue scales.
Timepoint [1] 323118 0
3-months post-ICU admission
Secondary outcome [2] 323119 0
To assess gastric emptying in survivors of critical illness compared to that of matched healthy controls using 13C-octanoic acid breath tests.
Timepoint [2] 323119 0
3-months post-ICU admission
Secondary outcome [3] 323120 0
To assess levels of hormones that may influence appetite (blood glucose, plasma GLP-1, GIP, and glucagon, and serum insulin, and C-peptide) in survivors of critical illness compared to that of matched healthy controls by plasma or serum assay.
Timepoint [3] 323120 0
On the study day (3-months post-ICU admission), fasting blood samples will be taken to assess the above hormone levels (following a 12 hour overnight fast).

Additional blood samples will then be taken every 30 minutes from study commencement (glucose tolerance and gastric emptying test) for 180 minutes. The final blood sample will be taken 15 minutes before the energy buffet.
Secondary outcome [4] 323121 0
To assess whether there is a correlation between energy intake measured in an energy buffet and gastric emptying measured using a 13C-octanoic acid breath test at 3-months post-critical illness.
Timepoint [4] 323121 0
3-months post-ICU admission
Secondary outcome [5] 324114 0
To assess whether there is a correlation between energy intake measured in an energy buffet and appetite hormones (serum, insulin, c-peptide, and plasma glucagon, GIP & GLP-1) at 3-months post-critical illness.
Timepoint [5] 324114 0
3-months post-ICU admission
Secondary outcome [6] 324115 0
To assess whether there is a correlation between energy intake measured in an energy buffet and self-reported appetite measured with visual analogue scales at 3-months post-critical illness.
Timepoint [6] 324115 0
3-months post-ICU admission

Eligibility
Key inclusion criteria
Patients will be identified through screening of intensive care admissions at the Royal Adelaide Hospital and will include all patients aged 30 years or older that have been discharged and are 3-months post-ICU admission.

Healthy volunteers aged >=30 years will be used as a comparator.
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Inability to give informed consent
2) Pregnant or breastfeeding
3) Previous gestational diabetes
4) Acute or chronic pancreatitis
5) Medications known to affect glucose metabolism (e.g. steroids) or gastrointestinal motility (e.g. prokinetics, antidepressants, sedatives, opiates, anti-convulsant agents)
6) Previous gastrointestinal surgery (apart from appendectomy)
7) Vegetarian/vegan
8) Current or previous gastrointestinal disease or major dysfunction
9) Regular consumption of >20g alcohol or >10 cigarettes per day


Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
In the absence of previous epidemiological data we are unable to perform a meaningful power calculation. Based on pooled data from 10 studies conducted within our unit, the assumed standard deviation for energy intake from an energy buffet is 1802kJ. Based on this, a sample size of 50 ICU patients with a 2:1 recruitment for healthy volunteers (n=25), with 80% power and significance level of 5% would provide a detectable difference in energy intake of 1253kJ. Energy intake and VAS scores from the ICU cohort will be compared against matched healthy controls and a difference of >10% will be considered as significant (Blundell, Graaf, Hulshof, 2010, obesity reviews).

Outcome variables will be summarised using standard descriptive statistics and analysed by a professional biostatistician (Ms. Kylie Lange) employed by the CRE in Translating Nutritional Science to Good Health using an appropriate inferential techniques.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 5668 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 13154 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 293484 0
Hospital
Name [1] 293484 0
Royal Adelaide Hospital
Address [1] 293484 0
North Terrace
Adelaide, SA, 5000
Country [1] 293484 0
Australia
Primary sponsor type
Hospital
Name
ICU Research, Royal Adelaide Hospital
Address
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 292306 0
None
Name [1] 292306 0
Address [1] 292306 0
Country [1] 292306 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294927 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 294927 0
North Terrace, Adelaide, SA, 5000
Ethics committee country [1] 294927 0
Australia
Date submitted for ethics approval [1] 294927 0
07/03/2016
Approval date [1] 294927 0
07/03/2016
Ethics approval number [1] 294927 0
R20131217 HREC/13/RAH/576

Summary
Brief summary
Anecdotally, survivors of critical illness reported reduced appetite that persists after discharge from ICU, however this has not been quantified, Given critical illness is associated with an increased prevalence of malnutrition, and functional deficits occur well after ICU discharge, factors that may influence recovery of nutritional status and hence function require exploration. This study is a sub-study to 'The significance of hyperglycaemia in survivors of critical illness and potential mechanisms underlying development of type 2 diabetes (ACTRN12614000449639) that will recruit ICU survivors and a healthy cohort.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65282 0
Ms Lee-anne Chapple
Address 65282 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 65282 0
Australia
Phone 65282 0
+61 8 70741763
Fax 65282 0
Email 65282 0
lee-anne.chapple@adelaide.edu.au
Contact person for public queries
Name 65283 0
Ms Lee-anne Chapple
Address 65283 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 65283 0
Australia
Phone 65283 0
+61 8 70741763
Fax 65283 0
Email 65283 0
lee-anne.chapple@adelaide.edu.au
Contact person for scientific queries
Name 65284 0
Ms Lee-anne Chapple
Address 65284 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 65284 0
Australia
Phone 65284 0
+61 8 70741763
Fax 65284 0
Email 65284 0
lee-anne.chapple@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary