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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
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Scientific title
Retrospective cohort study to determine if ultrastructural changes are present in duodenal biopsies of critically ill patients compared to ambulant volunteers
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Secondary ID [1]
282394
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malabsorption in critically ill patients
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Condition category
Condition code
Diet and Nutrition
289314
289314
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
287027
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Not applicable
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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.
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Control group
Historical
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Outcomes
Primary outcome [1]
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To determine if critical illness is associated with ultrastructural changes on duodenal mucosa. This will be analyzed with an electron microscopy.
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Assessment method [1]
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Timepoint [1]
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At time of endoscopy
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Secondary outcome [1]
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To determine if critical illness produces histpathologic changes in duodenum, assessed with a light microscope.
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Assessment method [1]
302451
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Timepoint [1]
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At time of endoscopy
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Eligibility
Key inclusion criteria
Ambulant volunteers who are planned to undergo an endoscopy for clinical reasons
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Both
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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).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
15
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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The Royal Adelaide Hospital - Adelaide
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country [1]
287170
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Australia
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Primary sponsor type
Individual
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Name
Adam Deane
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Address
Intensive Care Research Office
Level 4
Emergency Block, Royal Adelaide Hospital
North Terrace, 5005
South Australia
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Victor Liew
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Address [1]
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74/210 Grote St
Adelaide 5000
South Australia
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Country [1]
285935
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Royal Adelaide Hospital Research Ethics Committee
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Ethics committee address [1]
289166
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Level 3 Hanson Institute
IMVS building
Royal Adelaide Hospital
North Terrace, Adelaide 5000
South Australia
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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03/04/2013
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Approval date [1]
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08/04/2013
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Ethics approval number [1]
289166
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130320
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Adam Deane
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Address
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Intensive Care Research
Level 4, Emergency Block
Royal Adelaide Hospital
North Terrace, Adelaide 5000
South Australia
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Country
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Australia
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Phone
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+618 8222 2818
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Adam Deane
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Address
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Intensive Care Research
Level 4, Emergency Block
Royal Adelaide Hospital
North Terrace, Adelaide 5000
South Australia
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Country
39543
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Australia
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Phone
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+618 8222 2818
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Adam Deane
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Address
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Intensive Care Research
Level 4, Emergency Block
Royal Adelaide Hospital
North Terrace, Adelaide 5000
South Australia
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Country
39544
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Australia
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Phone
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+618 8222 2818
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Fax
39544
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Email
39544
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[email protected]
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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.
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