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Trial registered on ANZCTR


Registration number
ACTRN12608000579392
Ethics application status
Approved
Date submitted
12/09/2008
Date registered
19/11/2008
Date last updated
21/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of critical illness on small intestinal transit and nutrient absorption
Scientific title
A prospective observational study to measure small intestinal transit time and nutrient absorption in critically ill patients and compare the results to healthy volunteers
Secondary ID [1] 283426 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
critically ill patients 3679 0
Condition category
Condition code
Diet and Nutrition 4146 4146 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A meal will be administered into the small intestine. Small intestinal transit time is measured, using a label in the meal detected by gamma camera. Carbohydrate absorption is also measued, using plasma concentration of 3-O-Methyl-glucose which is an actively absorbed synthetic sugar.

Following the meal measurements will continue for 6 hours for one day only.

In the patient group I anticpate 20 patients will be compared to 10 healthy volunteers. Given most critically ill patients receive opiates for pain relief and/or sedation, patients receiving opiates will be included in the study. However opiate medication is reported to delay small intestinal transit in healthy volunteers. Given the above, 10 patients will be included who are already receiving opiate medication and 10 who are not. If there is a difference between the pre-defined subgroups this would generate the hypothesis that opiate medication does alter small intestinal transit in critical illness, which would then encourage us to test this in a randomised fashion.
Intervention code [1] 3391 0
Not applicable
Comparator / control treatment
Healthy volunteers will have the same meal. We will then measure the mean transit time and relationship to absorption in health. This will allow comparison to the critically ill group to assess if critical illness affects transit and/or absorption.
Control group
Active

Outcomes
Primary outcome [1] 4741 0
small intestinal transit time using a labelled meal and scintigraphic camera
Timepoint [1] 4741 0
4-6 hours
Primary outcome [2] 4742 0
nutrient absorption using plasma concentrations of 3-OMG
Timepoint [2] 4742 0
4-6 hours
Primary outcome [3] 4743 0
association between transit time and nutrient absorption using statistical analysis
Timepoint [3] 4743 0
4-6 hours
Secondary outcome [1] 8011 0
pre-defined subgroup of patients receiving opiate and not receiving opiate and compare transit time/nutrient absorption
Timepoint [1] 8011 0
2-8 hours

Eligibility
Key inclusion criteria
critically ill patients
sedated and mechanically ventilated
suitable for, or receiving small intestinal nutrition
Minimum age
17 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Any contraindication to placement of a post-pyloric feeding tube
contraindication to enteral feeding
Previous surgery on the duodenum/small intestine
Any gastrointestinal surgery during their current hospital admission
Patients receiving erythromycin at an antimicrobial dose

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

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] 1603 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 3858 0
Government body
Name [1] 3858 0
National Health and Medical Research Council (NHMRC)
Address [1] 3858 0
GPO Box 1421
Canberra ACT 2601
Country [1] 3858 0
Australia
Primary sponsor type
Individual
Name
Adam Deane
Address
c/- Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 3464 0
None
Name [1] 3464 0
Address [1] 3464 0
Country [1] 3464 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5912 0
Royal Adelaide Hospital Recearch Ethics Committee
Ethics committee address [1] 5912 0
IMVS Building
Royal adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [1] 5912 0
Australia
Date submitted for ethics approval [1] 5912 0
Approval date [1] 5912 0
01/01/2007
Ethics approval number [1] 5912 0
061020

Summary
Brief summary
Adequate nutrition is important to allow patients in the Intensive Care Unit the best chance of recovery from their illness. This is usually provided by feeding through a tube into the stomach. Unfortunately, many patients do not get enough nutrients from feeding into the gut, as the stomach and small intestine does not work normally. In these patients, symptoms such as diarrhoea and bloating are also common. We are doing research in this Intensive Care Unit to understand why the gut does not work normally in some patients and how this affects their absorption of nutrients. A greater understanding of how the gut functions during illness is important for treatment and to devise ways to improve the feeding of patients in Intensive Care.
Trial website
Trial related presentations / publications
A summary presentation entitled 'The effect of critical illness on enteral absorption of long chain triglycerides' was presented at the ANZICS Hobart Conference in October 2013.
Public notes

Contacts
Principal investigator
Name 28923 0
Dr Adam Deane
Address 28923 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 28923 0
Australia
Phone 28923 0
+618 8222 2818
Fax 28923 0
Email 28923 0
adam.deane@adelaide.edu.au
Contact person for public queries
Name 12080 0
Dr Adam Deane
Address 12080 0
c/- Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 12080 0
Australia
Phone 12080 0
+61 8 8222 4000
Fax 12080 0
Email 12080 0
adam.deane@adelaide.edu.au
Contact person for scientific queries
Name 3008 0
Dr Adam Deane
Address 3008 0
c/- Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide SA
5000
Country 3008 0
Australia
Phone 3008 0
+61 8 8222 4000
Fax 3008 0
Email 3008 0
adam.deane@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