ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

critically ill patients

Condition category

Condition code

Diet and Nutrition

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]

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]

small intestinal transit time using a labelled meal and scintigraphic camera

Timepoint [1]

4-6 hours

Primary outcome [2]

nutrient absorption using plasma concentrations of 3-OMG

Timepoint [2]

4-6 hours

Primary outcome [3]

association between transit time and nutrient absorption using statistical analysis

Timepoint [3]

4-6 hours

Secondary outcome [1]

pre-defined subgroup of patients receiving opiate and not receiving opiate and compare transit time/nutrient absorption

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

22/09/2008

Actual

1/07/2010

Date of last participant enrolment

Anticipated

1/07/2011

Actual

17/01/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Recearch Ethics Committee

Ethics committee address [1]

IMVS Building
Royal adelaide Hospital
North Terrace
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/01/2007

Ethics approval number [1]

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

Dr Adam Deane

Address

Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Country

Australia

Phone

+618 8222 2818

Fax

adam.deane@adelaide.edu.au

Contact person for public queries

Name

Adam Deane

Address

c/- Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000

Country

Australia

Phone

+61 8 8222 4000

Fax

adam.deane@adelaide.edu.au

Contact person for scientific queries

Name

Adam Deane

Address

c/- Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide SA
5000

Country

Australia

Phone

+61 8 8222 4000

Fax

adam.deane@adelaide.edu.au

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Postprandial rise of essential amino acids is impaired during critical illness and unrelated to small-intestinal function.	2022	https://dx.doi.org/10.1002/jpen.2103

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

Trial Review

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Documents added manually

Documents added automatically