Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000348459
Ethics application status
Not yet submitted
Date submitted
26/06/2007
Date registered
28/06/2007
Date last updated
28/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational study looking at the relationship between upper gut function and diarrhoea in Intensive Care patients
Scientific title
Diarrhoea in the critically ill: A Cohort study of the association between gastro-duodenal motility and diarrhoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diarrhoea in Critical illness 1905 0
Condition category
Condition code
Oral and Gastrointestinal 1995 1995 0 0

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prevalence of diarrhoea will be observed for 7 days post a motility study (a antro-pyloro-duodenal motility study) during enteral nutrition.

Specifically an assessment of:
i) Abnormal phase III activity during gastric feeding
ii) Abnormal Characteristics of the MMC (migrating motor complex) and
iii) proportion of each cycle (Quiescent, irregular or burst)

and the association between diarrhoea
Intervention code [1] 1855 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 2818 0
Diarrhoea (> 3 bowel liquid motions a day)
Timepoint [1] 2818 0
Secondary outcome [1] 4751 0
Nil
Timepoint [1] 4751 0

Eligibility
Key inclusion criteria
Ventilated critically ill patients.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to endoscopy (unstable c-spine or raised intra cranial pressure) previous upper GI (gastrointestinal) surgery. Laparotomy this admission. Contraindication to use of sedation.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
29
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2137 0
Hospital
Name [1] 2137 0
Royal Adelaide Hospital
Country [1] 2137 0
Australia
Primary sponsor type
Individual
Name
Adam Deane
Address
Country
Secondary sponsor category [1] 1941 0
Individual
Name [1] 1941 0
Marianne Chapman
Address [1] 1941 0
Country [1] 1941 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3931 0
(Royal Adelaide Hospital) ethics committee
Ethics committee address [1] 3931 0
Ethics committee country [1] 3931 0
Australia
Date submitted for ethics approval [1] 3931 0
Approval date [1] 3931 0
Ethics approval number [1] 3931 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27669 0
Address 27669 0
Country 27669 0
Phone 27669 0
Fax 27669 0
Email 27669 0
Contact person for public queries
Name 11044 0
Adam Deane
Address 11044 0
ICU
Royal Adelaide Hospital
4th Floor
North Terrace
Adelaide 5000 SA
Country 11044 0
Australia
Phone 11044 0
0431967560
Fax 11044 0
Email 11044 0
adam.deane@adelaide.edu.au
Contact person for scientific queries
Name 1972 0
Adam Deane
Address 1972 0
ICU
Royal Adelaide Hospital
4th Floor
North Terrace
Adelaide 5000 SA
Country 1972 0
Australia
Phone 1972 0
0431967560
Fax 1972 0
Email 1972 0
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
No additional documents have been identified.