ANZCTR - Registration

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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

5/07/2022

Date data sharing statement initially provided

5/07/2022

Date results information initially provided

5/07/2022

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]

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

Nutritional intake

Appetite

Condition category

Condition code

Diet and Nutrition

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]

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]

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]

3-months post-ICU discharge.

Secondary outcome [1]

To assess self-reported appetite in survivors of critical illness compared to that of matched healthy controls using visual analogue scales.

Timepoint [1]

3-months post-ICU admission

Secondary outcome [2]

To assess gastric emptying in survivors of critical illness compared to that of matched healthy controls using 13C-octanoic acid breath tests.

Timepoint [2]

3-months post-ICU admission

Secondary outcome [3]

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]

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]

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]

3-months post-ICU admission

Secondary outcome [5]

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]

3-months post-ICU admission

Secondary outcome [6]

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]

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

Sex

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

17/03/2016

Date of last participant enrolment

Anticipated

31/01/2017

Actual

31/01/2017

Date of last data collection

Anticipated

Actual

31/01/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Adelaide Hospital

Address [1]

North Terrace
Adelaide, SA, 5000

Country [1]

Australia

Primary sponsor type

Hospital

Name

ICU Research, Royal Adelaide Hospital

Address

North Terrace
Adelaide
SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Human Research Ethics Committee

Ethics committee address [1]

North Terrace, Adelaide, SA, 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/03/2016

Approval date [1]

07/03/2016

Ethics approval number [1]

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

Ms Lee-anne Chapple

Address

Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Country

Australia

Phone

+61 8 70741763

Fax

[email protected]

Contact person for public queries

Name

Ms Lee-anne Chapple

Address

Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Country

Australia

Phone

+61 8 70741763

Fax

[email protected]

Contact person for scientific queries

Name

Ms Lee-anne Chapple

Address

Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Country

Australia

Phone

+61 8 70741763

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Published on 01/06/2019 Chapple L. S. (2019). O... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Observed appetite and nutrient intake three months after ICU discharge.	2019	https://dx.doi.org/10.1016/j.clnu.2018.05.002

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically