Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000508774
Ethics application status
Approved
Date submitted
30/04/2013
Date registered
8/05/2013
Date last updated
14/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Microscopic comparison of samples of small intestine between critically ill patients and non-critically ill patients
Scientific title
Retrospective cohort study to determine if ultrastructural changes are present in duodenal biopsies of critically ill patients compared to ambulant volunteers
Secondary ID [1] 282394 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malabsorption in critically ill patients 288975 0
Condition category
Condition code
Diet and Nutrition 289314 289314 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
Comparison of duodenal ultrastructure between ambulant volunteers and critically ill patients. The duodenal samples from critically ill patients have already been collected as part of a previous study (Royal Adelaide Hospital Research Ethics Committee protocol number 051211). 6 duodenal samples were taken per patient for 15 patients, over the period of 2011-2012.

Therefore, 6 duodenal samples will be taken from each ambulant volunteer, and the total length of the endoscopy will not be significantly lengthened. An average endoscopy lasts around half an hour.
Intervention code [1] 287027 0
Not applicable
Comparator / control treatment
The duodenal samples from critically ill patients have already been collected as part of a previous study (Royal Adelaide Hospital Research Ethics Committee protocol number 051211). 6 duodenal samples were taken per patient for 15 patients, over the period of 2011-2012.
Control group
Historical

Outcomes
Primary outcome [1] 289427 0
To determine if critical illness is associated with ultrastructural changes on duodenal mucosa. This will be analyzed with an electron microscopy.
Timepoint [1] 289427 0
At time of endoscopy
Secondary outcome [1] 302451 0
To determine if critical illness produces histpathologic changes in duodenum, assessed with a light microscope.
Timepoint [1] 302451 0
At time of endoscopy

Eligibility
Key inclusion criteria
Ambulant volunteers who are planned to undergo an endoscopy for clinical reasons

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide informed consent

Known small intestinal pathology including coeliac disease, inflammatory bowel disease or cystic fibrosis

Suspicion of small intestinal pathology including coeliac disease
Active gastrointestinal bleeding

Ingestion, within the previous 7 days, of drugs known to alter platelet aggregation or thrombus formation, including:
i. Aspirin > 150mg/day;
ii. Any other non-steroidal anti-inflammatory drug;
iii. Thienopyridines (clopidogrel)

Patients on antibiotics known to effect gastrointestinal function

Patients whose religious belief prevents administration of blood product e.g. Jehovah’s Witness

Chronic alcohol abuse (> 5 standard drinks per day)

Previous bariatric or small intestinal surgery other than appendicectomy

Pregnancy or breast-feeding

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Data will be recorded for individual variables or as grouped data as appropriate. Depending on normality, the difference between groups will be assessed by Student’s unpaired t-test or the non-parametric equivalent. The null hypothesis will be rejected at a significance of 0.05.

The number of patients for this study is based on the number of patients in the comparative group i.e. the critically ill patients in whom we have already obtained biopsies (Royal Adelaide Hospital Research Ethics Committee protocol number 051211).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 948 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 287170 0
Government body
Name [1] 287170 0
National Health and Medical Research Council
Country [1] 287170 0
Australia
Primary sponsor type
Individual
Name
Adam Deane
Address
Intensive Care Research Office
Level 4
Emergency Block, Royal Adelaide Hospital
North Terrace, 5005
South Australia
Country
Australia
Secondary sponsor category [1] 285935 0
Individual
Name [1] 285935 0
Victor Liew
Address [1] 285935 0
74/210 Grote St
Adelaide 5000
South Australia
Country [1] 285935 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289166 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 289166 0
Level 3 Hanson Institute
IMVS building
Royal Adelaide Hospital
North Terrace, Adelaide 5000
South Australia
Ethics committee country [1] 289166 0
Australia
Date submitted for ethics approval [1] 289166 0
03/04/2013
Approval date [1] 289166 0
08/04/2013
Ethics approval number [1] 289166 0
130320

Summary
Brief summary
We hypothesize that ICU patients have changes in the structure of their small intestinal cells that predisposes them to malabsorption of nutrients.

To investigate this, we are comparing biopsies from 15 ICU patients and comparing them to biopsies from 15 healthy patients. We will analyse the samples with an electron microscope.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39542 0
Dr Adam Deane
Address 39542 0
Intensive Care Research
Level 4, Emergency Block
Royal Adelaide Hospital
North Terrace, Adelaide 5000
South Australia
Country 39542 0
Australia
Phone 39542 0
+618 8222 2818
Fax 39542 0
Email 39542 0
adam.m.deane@gmail.com
Contact person for public queries
Name 39543 0
Dr Adam Deane
Address 39543 0
Intensive Care Research
Level 4, Emergency Block
Royal Adelaide Hospital
North Terrace, Adelaide 5000
South Australia
Country 39543 0
Australia
Phone 39543 0
+618 8222 2818
Fax 39543 0
Email 39543 0
adam.m.deane@gmail.com
Contact person for scientific queries
Name 39544 0
Dr Adam Deane
Address 39544 0
Intensive Care Research
Level 4, Emergency Block
Royal Adelaide Hospital
North Terrace, Adelaide 5000
South Australia
Country 39544 0
Australia
Phone 39544 0
+618 8222 2818
Fax 39544 0
Email 39544 0
adam.m.deane@gmail.com

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
No additional documents have been identified.